phase, two included both subacute and chronic patients, and one did not report the time since injury. None of the studies was identified as exclusively or predominantly enrolling mild TBI patients. Studies ranged in sample size from 36 to 205 and were equally split between inpatient and outpatient settings. Seven studies were pre-post, single group design without any comparison or control group. However, there was a broad range in the quality of the design, execution, and reporting of the studies. Table 11-1 (at the end of the chapter) presents a summary of all included studies in this review.
The committee reviewed three RCTs (Salazar et al. 2000; Vanderploeg et al. 2008; Zhu et al. 2007) of multi-modal/comprehensive CRT in patients in the subacute phase of moderate-severe TBI; one nonrandomized, parallel group study (Bowen et al. 1999) of multi-modal/comprehensive CRT included patients in the subacute phase of recovery from mild, moderate, and severe TBI. All four studies enrolled patients within 6 months of their injury. Most significantly, all three RCTs had some element of CRT in their comparator arms. Thus, the goal of these studies was to determine whether there was a benefit of one form or level of intensity of CRT relative to another, early after injury. These studies were not designed to assess efficacy relative to no treatment or relative to an inert or minimal control condition, such as a waitlist group. Table 11-2 presents all subacute phase studies by design and treatment comparator.
Comparator Group: Non-CRT Content
Bowen et al. (1999), a single, nonrandomized, parallel group study, included 104 patients in the subacute phase with TBI severity ranging from mild to severe. The aim of the study was to evaluate outcomes of services provided by a community-based, interdisciplinary team of specialists— clinical psychologist, occupational therapist, family support nurse—all
|Study||Design||No Treatment||Non- CRT||Other CRT|
|Salazar et al. 2000||RCT||×|
|Vanderploeg et al. 2008||RCT||×|
|Zhu et al. 2007||RCT||×|
|Bowen et al. 1999||Parallel||×|