Cognitive Rehabilitation Therapy for Traumatic Brain Injury Model Study Protocols and Frameworks to Advance the State of the Science: Workshop Summary (2013) / Chapter Skim
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4 Key Themes
4 Key Themes
Pages 27-44
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From page 27... ...
Committee members had drafted the discussion questions, and a committee member moderated each small-group discussion. The discussion of the three papers was not intended to reassess the papers' conclusions; rather, the discussions were designed to elicit participants' suggestions about the elements of optimal research design and the succession of studies through the maturational process.
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From page 28... ...
This section of the summary highlights the overarching points raised about study design and addresses the challenges of creating and maintaining a research pipeline that has the necessary continuity between research approaches as a research program moves through the maturational process discussed by John Whyte and summarized in Chapter 3. Organization and Pace of the Maturational Process Individual participants offered several bird's-eye perspectives on research design.
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From page 29... ...
Looking more closely at the movement of a research program along the maturational process, participants examined the question of when a nascent study is ready to be optimized. They explored the question faced by researchers -- at the conclusion of a study -- of whether to move forward in the maturational process (toward larger studies)
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From page 30... ...
SEVERITY LEVELS OF TBI: DISCUSSION OF MILD INJURY Workshop participants individually offered suggestions and ideas concerning the needs specific to mild TBI, the form of TBI affecting the largest number of military personnel. Definitions and Distinctions Mild, Moderate, and Severe A participant raised the question of how the current classification of mild, moderate, and severe may affect research outcomes.
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From page 31... ...
Closing the Knowledge Gap The participants discussed the development of an action plan for mild TBI that would close the many gaps identified in the Institute of Medicine (IOM) report Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence.
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From page 32... ...
(This constitutes an examples of the "dismantling" approach discussed earlier.) COMPONENTS OF RESEARCH STUDIES AND THEIR CHARACTERISTICS AT DIFFERENT POINTS IN THE MATURATIONAL PROCESS Below is a thematic summary of suggestions offered by individual workshop participants in either the reporting-back sessions following smallgroup discussions or in discussions after the formal presentations.
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From page 33... ...
In contrast, a very focused intervention, such as attention process training, would be a good candidate for a more traditional, classical research design. Individual participants posited the following suggestions: • Pre-post or single-subject designs are useful.
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From page 34... ...
At this late stage of effectiveness research, it may be increasingly difficult to do randomized clinical trials. It may be necessary to rely more heavily on health services research, and as the Military Health System considers introducing procedures or programs, one thing they could consider is introducing them systematically and in staggered fashion such that we get naturalistic evidence of the impact of those introductions.
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From page 35... ...
. Interventions Individual participants remarked that it is important that an intervention be delivered uniformly and that the study design ensures that uniform delivery take place.
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From page 36... ...
Outcomes Select participants highlighted the importance of measuring and having data on patient-centered outcomes. The IOM report Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence found a relative paucity of research on patient-centered outcomes.
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From page 37... ...
However, having standard of care as the control does make recruitment very difficult; therefore, wait list controls may offer a potentially better alternative. Manuals Workshop participants identified the great need for the protocols and manuals necessary as a starting point to further investigate specific interventions for specific patient populations and to examine interventions' cost-effectiveness.
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From page 38... ...
The National Institute on Disability and Rehabilitation Research TBI Model System's National Database is available to the public. Deidentified data are provided to outside researchers who have an interest, and researchers often have the opportunity to collaborate with those who have contributed data to the TBI Model System Centers themselves.
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From page 39... ...
In later stages of the maturational process of research on CRT for TBI, it may be necessary to rely more heavily on health services research. As the Military Health System considers introducing CRT interventions, one strategy it may want to consider is introducing CRT interventions systematically and in staggered fashion, thus obtaining naturalistic evidence of the impact of those introductions.
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From page 40... ...
At the conclusion of the workshop, John Whyte led a discussion in which he outlined three broad research strategies that could guide research decisions and help decision makers balance urgency, evidence, and cost-effectiveness. Immediate Implementation One strategy that the military could consider would be to take a manualized treatment shown to have significant effects in patients' daily lives, implement it, and fund studies to elucidate the active and essential ingredients and mechanism of action.
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From page 41... ...
A Middle Way: A Quasi-Experimental Health Services Design Component A second strategy described by Whyte was a middle road, a path that beckoned somewhat less to the immediate need to implement interventions and leaned more toward establishing more robust evidence for an intervention's effectiveness. Selection of the Intervention In this case the intervention would be selected based also on a combination of existing evidence and the research target's clinical importance, in this instance putting somewhat more weight on the desirability of empirical evidence supporting an intervention's effectiveness.
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From page 42... ...
As the Military Health System considers implementing interventions that hold the promise of improving patients' lives, where should it focus, and why? The question for health services administrators and practitioners of CRT, in Whyte's view, comes down to finding an optimal way to make decisions -- the published evidence is not strong enough to guide decisions singlehandedly.
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From page 43... ...
In concrete terms, he noted how the original IOM report and the current workshop will be of great help to TRICARE and the Department of Defense as it makes more informed, focused program announcements in the future on CRT research directions. Finally, Davison reiterated the commitment of TRICARE to helping service members who suffer from TBIs of any type, and he asserted that the responsibility is on TRICARE's systems to better coordinate efforts and, ultimately, arrive at clinical guidelines for using CRT to treat TBI in a way that is effective, evidence-based, and the most efficient use of dollars possible.
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