Twamley 2014.
Methods |
Design: randomized controlled, trial comparing 2 alternative TBI treatment approaches. Randomization: computerized randomization in 1 block, 2‐arm, parallel group. Duration of study: September 2008 to February 2012. |
|
Participants |
Number randomized: 50 adult veterans with mild‐to‐moderate TBI. Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
Intervention: supported employment + cognitive Symptom Management and Rehabilitation Therapy (cogSMART). Portable and practical intervention designed to be implemented without extensive training. 12‐week, multi‐modal compensatory cognitive training intervention emphasizing habit learning and compensatory strategies in prospective memory, attention, learning, memory and executive functioning. The treatment manual was informed by consultation with the acquired brain injury programme at Mesa College in San Diego, CA, and other cognitive remediation experts. Control: enhanced supported employment without cogSMART. Duration: 12 weeks. 1 employment specialist delivered CogSMART for 1 hour per week in addition to 1 hour of standard supported employment, to make it 2 visits per week. For the control group, another employment specialist delivered enhanced supported employment, making it 2 visits per week. |
|
Outcomes | Return to work: data on attainment of competitive work by 14 weeks collected on a weekly basis. QUality Of Life Interview ‐ Brief version (QUOLI‐Brief). Wide Range Achievement Test 3rd edition (WRAT‐3) Reading test. Prospective memory ‐ Memory for Intentions Screening Test (MIST). Wechsler Adult Intelligence Scale ‐ 3rd edition. California Verbal Learning Test ‐ 2nd edition. Delis‐Kaplan Executive Function System (D‐KEFS). Wisconsin Card Sorting Test. Postconcussive symptoms ‐ Neurobehavioral Symptom Inventory (NSI). Clinician Administered PTSD (post‐traumatic stress disorder) scale (CAPS). Hamilton Depression rating scale (HAM‐D). |
|
Notes |
Setting: hospital rehabilitation centre. Country: US. Duration of follow‐up: up to 2 weeks after completion of 12 weeks' intervention. Dropouts: of the 50 randomized, 8 (4 from each arm) reported to have dropped out. Post‐intervention data available only for 34 participants, 16 in the intervention arm and 18 in the control arm. Funding: project was "based on work supported by the Department of Defense (award W81XWH‐08‐2‐0193)." |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was carried out by the principal investigator using a randomisation scheme generated by Randomization.com, with 50 participants in one block." |
Allocation concealment (selection bias) | High risk | Comment: concealment of allocation could not have been plausible since the principal investigator carried out randomization using an online generator. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: though the participants and personnel were not blinded, this is unlikely to introduce bias in the objective outcome of return to work. |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: "Outcome assessment was not blinded; however, most of our outcome measures were either objective (neuropsychological test performance, attainment of competitive work) or reported by the participant." |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Fifty Veterans receiving healthcare at the VA San Diego Healthcare System enrolled in the study". "Eight participants dropped out, four from each group (two decided not to pursue work, one moved, and five were lost to follow‐up). Posttreatment data were available for 34 participants at 3 mo [months]." Comment: of the 16 dropouts (32% of the participants initially randomized), only 8 were accounted for. |
Selective reporting (reporting bias) | Low risk | Comment: though no details were available regarding prospective registration of the trial protocol, the outcomes reported were adequate from a trial of this nature. |
Other bias | Low risk | Comment: no other bias detected. |