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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3 The Translational Pipeline and Classification Schemes for CRT Interventions
3 The Translational Pipeline and Classification Schemes for CRT Interventions
Pages 13-26
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From page 13... ...
He described how pharmaceutically based translational research follows a relatively rigid series of steps that have different sample sizes and different typical research designs, and that are designed to answer different research problems as the maturational process 13
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Whyte highlighted a number of elements of the definition of translational research as translating the findings of basic research into medical practice and thus meaningful health outcomes. Basic research encompasses not just the typical understanding of basic research as dealing with the cellular level, but also basic cognitive science.
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. Treatment theory specifies the mechanism by which a proposed treatment affects its immediate treatment target, defining the essential ingredients of the treatment that are required to effect the change in the object.
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is what defines the treatment and distinguishes it from other treatments.1 In rehabilitation, the set of treatment theories is heterogeneous, with theories hailing from a wide range of fields including physiology, social theory, bioengineering, and many others. To illustrate the use of a treatment theory and the clarity that it can offer, Whyte gave examples of CRT treatments as well as familiar, physical treatments.
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Enablement Theory Whyte described enablement theory, which addresses the causal relationships among variables at different levels in the International Classification of Functioning Disability and Health (ICF) , which separates function into several levels, including tissue, organ function, and personal activity, and social integration (Figure 3-2)
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The outcome of an enablement theory is a treatment target, a clinically important treatment outcome that is often distal from (removed or more complex than) the more immediate treatment object.
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In pharmaceutical research, in which the active ingredient is known and consists of a specific molecule, the use of a placebo allows the researcher to control for all other variables. In behavioral research it is very hard to mask the active ingredient because the interventions involve the performance of meaningful tasks.
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Second Stage: Efficacy Studies Once the initial research has shown the intervention to work as intended in a small group of patients, the next stage in the maturational process involves efficacy studies in larger groups of patients and with interventions delivered by a larger number of practitioners. These studies are still largely guided by treatment theory.
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Regarding this third stage, Whyte noted that it can be increasingly difficult to do randomized clinical trials, and researchers may need to rely more heavily on health services research. Whyte suggested that, as the Military Health System considers introducing certain CRT interventions, one thing it might consider is to introduce them systematically and in staggered fashion in order to produce naturalistic evidence of the effect of those interventions.
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GUIDELINES FOR CREATING MEANINGFUL DESCRIPTIONS OF CRT INTERVENTIONS Current State of Practice Marcel Dijkers, Senior Investigator, Brain Injury Research Center of Mount Sinai Hospital, discussed common descriptions of rehabilitation interventions, focusing on their generality and arguing for greater specificity in order to more efficiently advance a broader research agenda. Therapy descriptions of the most general type specify only the number of hours provided and the type of health care professional who provided them (e.g., 2 hours of physical therapy and 6 hours of occupational therapy)
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. He found Current Procedural Terminology problematic for CRT-related terms because it sometimes gathered together interventions under one code that warranted separate codes and, conversely, it sometimes split multiple interventions among different codes when they ought to have shared just one.
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Content of Interventions and Dose Dijkers discussed dose and dosage as a way to think through important issues concerning active ingredients. In the pharmacological model that informs the current notion of dosage, the active ingredient is a molecule and dosage is defined in terms of quantity of the molecules given per certain characteristics of the patient -- body weight, severity of disease or disorder, and so on.
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From page 25... ...
. Dijkers recommended these papers as examples of sound thinking on the questions of dosage, but noted that the authors had not begun to think in terms of active ingredients and how to quantify, measure, and operationalize them -- indicating that even they had a long way to go before arriving at a research design capable of constituting a solid step along the translational pipeline.
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