individual, the type and extent of comorbidities, or the type and one or more cognitive deficits. Furthermore, the unique characteristics of the individual 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.


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 particular 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.


The IOM Clinical Research Roundtable developed a now widely accepted conceptual model of the research stages (Sung et al. 2003). As depicted 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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