BOX 6-1
Inclusion and Exclusion Criteria

1.0 Participants

1.1 Sample is composed of individuals with TBI (open or closed, with or without secondary hypoxic/ischemic injury), as evidenced by

a. Initial loss/alteration of consciousness on clinical assessment (abnormal GCS or posttraumatic amnesia); OR

b. Findings on neuro-imaging consistent with TBI; OR

c. Focal impairment on neurologic exam consistent with TBI; OR

d. Documentation of injury for patients with mild TBI (plausible history is sufficient for patients with moderate-severe TBI);

OR

1.2 Sample is mixed between TBI and non-TBI but results are reported separately for TBI subjects (who meet the above definition); OR

1.3 Sample is mixed but contains a majority of TBI participants; AND

1.4 Sample is composed of individuals age 18 or older.

2.0 Treatment

2.1 The intervention is sufficiently described for classification/categorization as CRT; AND

2.2 Studies that primarily evaluated drug efficacy are excluded.

3.0 Outcome Measures

3.1 Outcome measure(s) could be either objective or subjective measures; AND

3.2 Studies where the only outcome measures are performance of tasks that were directly practiced in the treatment protocol are excluded.

4.0 Study Design

4.1 Uncontrolled case reports or case series are excluded.

4.2 Single subject experimental designs (i.e., designs focusing on outcome within a subject, while incorporating experimental controls) are included.

4.3 For pre-post studies conducted during a postinjury period and over a duration in which substantial change might be expected in the primary outcome(s), studies with no comparison group (since measured improvement may be “spontaneous”) (e.g., if mild TBI occurred over 6 months or fewer, and moderate-severe TBI occurred over 12 months or fewer) are excluded.

4.4 For studies conducted in a postacute period, pre-post studies with no comparison group and only subjective self-report outcomes (which may be strongly affected by expectation) are excluded.

5.0 Other

5.1 Only studies available in the English language are included.



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