TEC Assessment Index
Cognitive Rehabilitation for Traumatic Brain Injury in Adults
Executive Summary
Background
Traumatic brain injury can cause cognitive difficulties. Cognitive rehabilitation comprises a variety of intervention strategies or techniques that attempt to help patients reduce, manage, or cope with cognitive deficits caused by brain injury.
Objective
To determine whether there is adequate evidence to demonstrate that cognitive rehabilitation results in improved health outcomes. For the purposes of this Assessment, cognitive test performance is not considered a health outcome. Results of instruments assessing daily functioning or quality of life are considered health outcomes.
Search Strategy
Randomized, controlled trials of cognitive rehabilitation for traumatic brain injury cited in recent systematic review articles were obtained. MEDLINE® was searched (via PubMed) through January 2008 for randomized, controlled trials of cognitive rehabilitation. Rehabilitation programs characterized as "multidisciplinary" or "coordinated" were not considered cognitive rehabilitation unless the paper specifically stated that the program incorporated cognitive rehabilitation components or theory.
Selection Criteria
For the main evidence review, randomized, controlled trials of cognitive rehabilitation were selected. A recent nonrandomized study of a comprehensive holistic program of cognitive rehabilitation was also included.
Main Results
Two studies of comprehensive holistic cognitive rehabilitation were reviewed. The one randomized study found no differences in the outcomes of return to work, fitness for military duty, quality of life, and measures of cognitive and psychiatric function at 1 year. Rates of returning to work were greater than 90% for both the intervention and control groups, raising the question whether the subjects included in the study were not severely injured enough to be able to demonstrate an effect of rehabilitation. The other study of comprehensive rehabilitation was nonrandomized. The intervention group showed greater improvements in functioning as assessed by a questionnaire that evaluated community integration, home integration, and productivity assessed upon completion of the intervention. However, there were many differences in baseline characteristics between intervention and control groups, particularly regarding the time since injury. Patients were not followed beyond completion of the intervention program.
Eleven randomized, controlled trials of cognitive rehabilitation for specific cognitive defects showed inconsistent support for cognitive rehabilitation. Out of the 11 studies, 8 reported on health outcomes. Three of the studies showed statistically significant differences between intervention groups and control groups on one outcome. However, 2 of the studies were extremely small. The findings were not consistent across other outcomes measured in the studies, and in one study, significant findings after the intervention were no longer present at 6 months of follow-up.
All 11 studies also reported outcomes of various cognitive tests. We did not consider these to be valid outcomes for the purposes of assessing health benefit. Evaluation of these cognitive test outcomes is plagued by numerous methodologic problems, such as small sample size, lack of long-term follow-up, minimal interventions, and multiple outcomes. Seven of the studies reported at least one outcome showing that cognitive rehabilitation was associated with better performance on a specific cognitive test. Of these positive studies, 2 of them had no follow-up beyond the time of treatment, and 2 had sample sizes smaller than 20. In only one study was there consistency across several cognitive test scores showing better performance with cognitive rehabilitation.
Authors' Comments and Conclusions
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.
TEC Assessment Index
NOTICE OF PURPOSE:TEC Assessments are scientific opinions, provided solely for informational purposes. TEC Assessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated.
activities daily living; ADL; adults; attention; behavioral deficits; cognition; communication skills; Community Integration Questionnaire; compensatory; comprehensive; concentration, visual processing; concussion; continuum; deficits; Dysexecutive Questionnaire; emotional regulation; executive functions; holistic; injury; integration; language; memory; milieu; mnemonics; motor control; motor skills; neuropsychological; notebook; Paced Auditory Serial Attention Task; PASAT; problem-solving; pseudorehabilitation; psychosocial; reasoning; remediation; social behavior; TBI; test scores; training; trauma;
