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Appendix A
Comparative Effectiveness and
Implementation Research for
Neurocognitive Disorders:
Concepts Relevant to Cognitive
Rehabilitation Therapy for
Traumatic Brain Injury
TASKS RELATED TO COMPARATIVE EFFECTIVENESS RESEARCH
The Institute of Medicine (IOM) Committee on Cognitive Rehabilitation
Therapy (CRT) for Traumatic Brain Injury (TBI) was asked to determine if
there is sufficient evidence to support widespread use of CRT interventions
in the Military Health System (MHS), including TRICARE coverage. In the
Statement of Task, the committee was charged with assessing the literature
not only for efficacy but also for effectiveness (“the committee will consider
comparison groups such as . . . other non-pharmacological treatment”) as
well as any evidence of harm or safety issues. Thus, subtasks 1 through 3 of
the Statement of Task to the committee include requests for analysis of any
existing literature that directly compares alternative treatment approaches.
Such an analysis directly falls within the definition of comparative effective-
ness research (IOM 2009).
A primary tenet of comparative effectiveness research is to evaluate
which preventions and treatments work for which patients. This tenet
reflects “the growing potential for individualized and predictive medicine—
based on advances in genomics, systems biology, and other biomedical
sciences—through the analysis of subgroups with demographic, ethnic,
physiologic, and genetic characteristics that could be useful factors in
clinical decisions” (IOM 2009). CRT interventions are multi-faceted, and
by definition, tailored to the particular individual. Interventions intend to
address not only specific domains of cognitive impairment, but also poten-
tial mediators and moderators of a CRT intervention’s effect (Figure A-1).
These mediators or moderators may include characteristics unique to the
273
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274
Potential Mediators
Comprehensive
and Moderators of
CRT
Comprehensive
CRT Effectiveness
Change Due to Outcomes:
Comprehensive Personal factors Participation in
Post-Acute TBI § Age
CRT Society;
§ Coping
Impairments Outcomes:
Restorative: Quality of Life
§ Extent and type of
Lessening of Activities
physical comorbidities Improvements
Impaired Cognitive impairment in one or Improvement
and symptoms* and in:
Domain more cognitive in ability to
their treatment quality § Employment
§ Attention domains carry out
§ Substance abuse status
§ Language and
important § Role in the
communication
daily activities
AND/OR Environment home
§ Memory
in the person’s
§ Social support § Educational
§ Visuospatial
physical and
Compensatory: § Disability supports/ attainment
perception
social
§ Lessening of service status § Community
§ Executive function
disabling impact environment
§ Transportation access participation
of one or more § Quality of life
impaired Adeguacy/quality of and well-
cognitive domains delivery of the being
Deficit awareness
§ Increase in deficit comprehensive CRT § Family/
awareness intervention caregiver
§ Appropriately trained health
Psychological co- AND/OR
providers
morbidity:
§ Standardized manuals
§ Fatigue Reduction in
and equipment/
symptoms of
§ Anxiety
facilities
psychological co-
§ Depression
morbidity
§ PTSD
Interference among
treatment components**
FIGURE A-1 Model for multi-modal/comprehensive CRT.
* For example: visual impairment, headache, dizziness.
** For example: side effect of medication for depression interferes with attention.
F igure 4-2 Broadside
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275
APPENDIX A
individual, the type and extent of comorbidities, or the type and one or
more cognitive deficits. Furthermore, the unique characteristics of the indi-
vidual may reflect preexisting conditions or factors unrelated to TBI, such
as presence of a sleep disturbance or extent of family support to enhance
participation in or reinforcement of the intervention.
TASKS RELATED TO IMPLEMENTATION RESEARCH
The committee was also asked to assess adequacy of the “training,
education, and experience” of providers of CRT, which falls within the
scope of implementation research. Such research aims to analyze whether
clinical interventions with evidence of efficacy are being delivered in real-
world, nonexperimental settings by usual providers, and if so, whether the
interventions continue to have a net health benefit. Thus, implementation
research not only observes levels of care and barriers to provision of high-
quality care, but also designs and evaluates policy or health care delivery
system interventions that may improve the uptake or delivery of a clinical
therapy. In that way, the health benefit of a therapy—across a population—
is maximally achieved in the context of its value. This issue is particularly
relevant to CRT, since such interventions are more complex than delivery
of a drug and require
1. Availability of specific protocols and tools for delivering a particu-
lar CRT intervention,
2. Adequately trained CRT providers, and
3. A context that maximizes sufficient participation by the patient to
achieve the benefit of the CRT.
TRANSLATING EVIDENCE INTO PRACTICE THROUGH
PHASED IMPLEMENTATION AND EVALUATION
The IOM Clinical Research Roundtable developed a now widely ac-
cepted conceptual model of the research stages (Sung et al. 2003). As de-
picted in Figure A-2, research stages include discovery of disease mechanisms
in the laboratory, development of efficacious therapeutics, and translation
of evidence-based therapies into widespread practice. To translate evidence-
based therapies to care generally calls for a phased series of studies, due to
the need to reengineer or redesign the way care is usually delivered. These
kinds of behavior or organizational changes are often complex, and initial
implementation approaches require extensive investigator involvement in
design and oversight of the change process. Strategies that are successful
in more tightly controlled environments must become broadly disseminated
in heterogeneous care settings, with less investigator involvement.
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276
Higher use of Improved
RCT-proven population
ion health
treatments*
s
ffu
Di
Clinical
Science and Clinical Quality
Translation
Translation from Basic
Basic Knowledge of Improvement or
into “real-
Neuroscience to
Research Potential Value Policy
world”
Human Studies
under Ideal Interventions
settings
Conditions
No
Lower,
dif
fus
delayed, or
ion
inappropriate
use of
RCT-proven
treatments
Implementation
Comparative
Research
Effectiveness
Research
FIGURE A-2 Clinical research continuum.
SOURCE: Vickrey et al. (submitted).
Figure A-2 Broadside
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APPENDIX A
Furthermore, change strategies apply evaluations later in the process,
focusing on a qualitative analysis of how and how well the intervention
is implemented, and whether the intervention continues to have beneficial
impact (Figure A-3) (Stetler et al. 2008). These kinds of evaluations are
particularly relevant for nonpharmacological interventions like CRT. For
an example beyond TBI literature, interventions to facilitate behavioral or
lifestyle changes in diet and physical activity for hypertension control utilize
these evaluations (Appel et al. 2003).
CRT FOR TBI AND COMORBIDITIES COMMON
IN THE MILITARY SETTING
The literature reviewed for this report illustrates that TBI occurring in
a military context is commonly accompanied by comorbidities, including
symptoms of psychological distress and possible co-occurring diagnoses
of depression, posttraumatic stress disorder (PTSD), or anxiety disorder.
Physical comorbidities also may exist, including pain, fatigue, sleep dis-
turbance, visual impairment, or effects of polytrauma from blast injuries.
The recognition and management of these comorbidities will impact end-
indicator outcomes such as health-related quality of life or employment;
Implementation Research
Effectiveness:
Guidelines and
systematic
Improved Health
reviews Interventional
Processes,
implementation
Outcomes
studies
Observational:
Quality gaps,
implementation
process
Phase 4
Phase 2 Phase 3
Phase 2 Phase 3
Phase 1
Phase 1
“Post-Marketing”
Small-Scale Large-Scale
Small-Scale Large-Scale
Pilot Projects
Pilot Projects Monitoring,
Efficacy Trials Effectiveness
Efficacy Trials Effectiveness
Refinement
Trials
Trials
FIGURE A-3 Refined research-implementation pipeline.
SOURCE: Adapted from Stetler et al. 2008.
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278 COGNITIVE REHABILITATION THERAPY FOR TBI
these outcomes are also targeted by rehabilitation directed toward specific
or multiple cognitive domains. The recently funded Defense and Veterans
Brain Injury Center (DVBIC) SCORE! trial began enrollment in 2011.
The study addresses pervasive TBI comorbidities through inclusion of a
comparator arm in which both cognitive and psychological comorbidities
are systematically screened for and addressed in a strategy tailored to the
individual. This clinically pragmatic approach recognizes that multiple,
applicable, efficacious clinical interventions should be tailored to the prob-
lems of the individual, both the primary cognitive domain(s) affected and
any comorbidities. This approach is analogous to those developed and
tested for certain chronic conditions that have a broad range of symptom
manifestations.
For example, Alzheimer’s disease not only affects memory but also is
often accompanied by a wide and varied range of behavior problems and
depression in the patient; safety issues; as well as depression, anxiety, and
stress in family caregivers. To successfully delay declines in patient health
outcomes and to improve caregiver outcomes requires screening for prob-
lems, prioritizing goals with the patient and the caregiver, and implementing
and following up on care management protocols likely to maximize benefit
for that patient–caregiver dyad (Vickrey et al. 2006). In general, U.S. health
care is moving toward care delivery strategies for chronic diseases that are
preventive; ongoing; include structured, systematic assessments; engage the
patient in self-management; and utilize health information technology (IT)
to make care delivery more efficient (Wagner et al. 1996). This trend is in
contrast to the traditional model of doctor visit–based care, which is more
reactive to problems and arose from an era in which acute therapy for
problems such as infections and injuries was the standard.
Evidence for the efficacy of CRT for specific domains of cognitive
impairment can guide clinical decision making and coverage decisions
for individuals with deficits in those domains with similar contexts and
clinical profiles as participants in those trials. Yet most individuals with
blast-related TBI have other comorbidities not studied in civilian trials.
Several studies that research multi-faceted interventions to address multiple
comorbidities and broader affected populations are under way (see Ap-
pendix C). The findings from these trials will need to be incorporated into
future coverage and clinical service decisions to inform subsequent research
studies that aim to build on those findings.
RESOURCES FOR COMPARATIVE EFFECTIVENESS RESEARCH
APPLICABLE TO ONGOING RESEARCH ON CRT FOR TBI
Prospectively planned analyses of clinically rich data sets are increas-
ingly used to monitor and evaluate the implementation and impact of
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279
APPENDIX A
clinical and policy interventions in health care. These analyses enable re-
searchers to reassess effectiveness—including both benefits and harms—of
interventions as they move into routine care from controlled settings and
populations where they have been tested for efficacy. Types of research ap-
proaches used for comparative effectiveness and implementation research
include systematic reviews, randomized trials, modeling, and observational
studies. Observational studies are potentially less expensive to perform than
randomized trials. However, observational studies require sufficient clinical
variables to enable meaningful analyses, considering disease severity and
factors that would influence choice of treatment and outcomes. Likewise,
analyses to compare outcomes of different treatment approaches should
account for these factors.
The Patient Centered Outcomes Research Institute, a private, non-
profit organization established in 2011, includes a Methodology Commit-
tee charged with identifying areas of research to improve the quality of
findings from comparative effectiveness studies, particularly observational
study designs. An evolving resource that will make observational studies of
comparative effectiveness more useful and feasible to conduct is the growth
of longitudinal patient registries. Such registries go beyond administrative
claims data, which typically lack sufficient clinical data on disease severity.
Larger, integrated health care delivery systems are creating registries that
link administrative claims data with pharmacy data, laboratory data, elec-
tronic medical records, and increasingly, patient-reported data collected in a
systematic fashion, to minimize missing data on key variables (Paxton et al.
2010). In the case of CRT in the MHS, a registry could be used to analyze
implementation of CRT and the associated outcomes. Such a registry would
need to prospectively collect additional data elements, including operation-
ally defined categories or a taxonomy of CRT treatments, as well as the
ability to assess (i.e., through analysis of a sample of cases) the extent to
which care consistent with CRT is currently delivered by physical therapy,
occupational therapy, speech therapy, or other providers. Doing so allows
for capture of current patterns and any changes over time via new or modi-
fied policy or expanded, evidence-based practices.
The growth in technological capacity for electronic medical records
and the national investment in health IT capability are fueling the op-
portunity to build registries with clinical utility, with few downsides.
A registry resource would ideally allow for ongoing investigations of
the effectiveness of CRT delivery and coverage policies in the MHS and
TRICARE by enabling researchers to access deidentified data (with appro -
priate approvals) and other resources. This access would help research-
ers ensure data or a subset of clinically enriched data are prospectively
captured and updated. This type of investment will ensure the timely and
efficient conduct of
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280 COGNITIVE REHABILITATION THERAPY FOR TBI
1. Future research on effectiveness and implementation of alternative
CRT approaches for members of the military and veterans,
2. Analyses to be used by health care administrators to make decisions
about the personnel and resources currently in place and needed in
the future to broadly implement CRT interventions identified as of
value for certain populations, and
3. Policy analyses on health and cost consequences of existing CRT
coverage policies, which will guide future recommendations for
changes in coverage for these clinical services as the evidence base
and the affected population change over time.
There are many strategies for establishing a registry. Ideally, specific
data elements on the delivery of CRT would be built into new or recently
created registries and observational studies sponsored by the U.S. Depart-
ment of Defense (DoD) and U.S. Department of Veterans Affairs (VA),
including the congressionally mandated 15-year longitudinal study of TBI
outcomes in soldiers being carried out by DVBIC.
POTENTIAL OPPORTUNITIES
Opportunities for advancing knowledge of what works for CRT in
TBI and for efficiently translating that knowledge into health care delivery
systems and maximizing health outcomes include the following:
• In currently planned DoD and VA registries, purposefully embed
the necessary data elements about types of CRT and providers, to
prospectively analyze current care patterns and costs, and factors
associated with variation (Gliklich and Dreyer 2010).
• Prospectively plan to evaluate current care and any changes in re-
sponse to policy decisions or new evidence, analogous to the VA’s
QUERI program and REACH program (Gitlin et al. 2010; Nichols
et al. 2011). Outcomes to be assessed in such an evaluation are im-
pact on utilization, benefits, harms, families, and unmet need, as well
as quality of care delivered relative to current or usual care patterns.
• Account for heterogeneity of populations and forthcoming ad-
vances in disease mechanisms and markers by designing studies of
CRT interventions or programs for TBI to include subgroup-level
results, as done with comparative effectiveness research on differ-
ent modes of health care delivery (Kent et al. 2010). This can be ac-
complished by ongoing surveillance for new evidence, particularly
on subgroup effectiveness (Shekelle et al. 2009).
• Create a publicly accessible database of the interventions, including
tools (manual, protocols, other resources) for delivering them, fa-
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APPENDIX A
cilitating implementation of new evidence about CRT. This would
also enable qualitative analysis of what components appear com-
mon to effective interventions, analogous to the Rosalynn Carter
Caregiving Institute database of effective caregiver interventions.
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