The randomized trial literature of cognitive rehabilitation does not show strong evidence for efficacy in the treatment of traumatic brain injury. Many of the clinical trials of specific cognitive rehabilitation interventions evaluated cognitive tests rather than health outcomes. Demonstration of the effectiveness of cognitive rehabilitation, either as an integrated holistic program, or as a separable component that treats a specific cognitive defect, requires prospective randomized designs that employ validated measures of health outcomes.
Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel made the following judgments about whether cognitive rehabilitation for traumatic brain injury in adults meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria.
1. The technology must have final approval from the appropriate government regulatory bodies.
Cognitive rehabilitation is a procedure and, therefore, is not subject to U.S. Food and Drug Administration (FDA) regulation.
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The number of clinical trials is relatively small. Many of the studies suffer from small sample sizes, insufficient follow-up, and lack of assessment of health outcomes. Only the nonrandomized study shows benefits of cognitive rehabilitation in terms of health outcomes. Unknown biases in the selection of subjects for inclusion in the cognitive rehabilitation program may have confounded the results of the study.
3. The technology must improve the net health outcome; and
4. The technology must be as beneficial as any established alternatives.
Most of the randomized studies do not show an improvement in health outcomes after a program of cognitive rehabilitation. The one nonrandomized study showing improvement in health outcomes had differences in types of patients enrolled in the two groups, and no long-term follow-up beyond the end of the cognitive rehabilitation program.
5. The improvement must be attainable outside the investigational settings.
Whether cognitive rehabilitation improves health outcomes in adults with traumatic brain injury has not been demonstrated in the investigational setting.
Based on the above, cognitive rehabilitation for traumatic brain injury in adults does not meet the TEC criteria.