Vanderploeg 2008.

Methods	Design: randomized, controlled, intention‐to‐treat trial comparing 2 alternative TBI treatment approaches. Single blind (outcome assessors). Randomization: 2‐arm, parallel group, stratified by centre, blocked in randomly ordered block sizes. Duration of study: not reported.
Participants	366 adult veterans or active duty military service personnel with moderate‐to‐severe TBI. 184 in the cognitive didactic rehabilitation arm and 182 in functional experiential rehabilitation arm. Inclusion criteria: moderate‐to‐severe non‐penetrating TBI within preceding 6 months manifested by a postresuscitation GCS score ≤ 12, or coma ≥ 12 hours, or post‐traumatic amnesia ≥ 24 hours, or focal cerebral contusion or haemorrhage on computerized tomography or magnetic resonance imaging. Rancho Los Amigos scale stage 5‐7. aged ≥ 18 years; active duty military personnel or veteran; anticipated length of needed acute interdisciplinary rehabilitation ≥ 30 days. Exclusion criteria: history of prior inpatient rehabilitation for current TBI; history of prior moderate‐to‐severe TBI, or other preinjury severe neurological or psychiatric condition such as psychosis, stroke, multiple sclerosis or spinal cord injury.
Interventions	Intervention 1: cognitive‐didactic. 4 cognitive domains targeted: attention, memory, executive functions and pragmatic communication. Paper and pencil, or computerized cognitive tasks in 1 to 1 cognitive therapy sessions given. Trial‐and‐error learning approach used. Therapists frequently asked questions calling attention to participant's self‐awareness. Intervention 2: functional‐experiential rehabilitation therapy. Real‐life performance situations and common tasks were used to remediate or compensate for functional deficits after brain injury. Functional protocol treatment interventions occurred in group setting and natural environments. Treatment focused on learning and doing functional daily activities using an errorless treatment strategy. Therapists emphasized instructional cues and attempted to anticipate and minimize participant errors by providing structure or directions. Duration: 1.5‐2.5 hours' daily of protocol‐specific therapy in addition to 2‐2.5 hours daily of occupational therapy and physiotherapy to both groups. Duration of protocol treatment days varied from 20 to 60 days depending on the clinical needs and progress of each participant.
Outcomes	Functional independence (ability to live independently with < 3 hours of assistance per week). Return to work or school (current status of paid employment or school enrolment either full or part time, not sheltered workshop). These were determined by structured interview questions. Secondary outcomes were FIM, Disability Rating Scale score and items from the Present State Exam, Apathy Evaluation Scale and Neurobehavioral Rating Scale.
Notes	Setting: acute inpatient rehabilitation brain injury programmes at 4 participating Veterans Administration Medical Centres in Minneapolis, Palo Alto, Richmond and Tampa. Country: US. Duration of follow‐up: 1 year. Dropouts: cognitive didactic group, 3 rescinded consent before protocol treatment began, 13 lost to follow‐up. Functional experiential group, 2 rescinded consent before protocol treatment began, 16 lost to follow‐up. 1‐year analysis on 360 participants. Funding: Defense and Veterans Brain Injury Center, Uniformed Services University of the Health Sciences, Bethesda, MD, the Department of Veterans Affairs, Veterans Health Administration, and a Department of Defense award administered through the Henry Jackson Foundation (grant no. MDA 905‐03‐2‐0003).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Participants were randomized to the comparative treatments by an independent study statistician using random number tables. Randomization was stratified by centre and blocked in randomly ordered block sizes. This method provides approximately even group assignments across centres and is recommended for multicenter clinical trials."
Allocation concealment (selection bias)	Low risk	Quote: "Participants were randomized to the comparative treatments by an independent study statistician using random number tables. Randomization was stratified by centre and blocked in randomly ordered block sizes. This method provides approximately even group assignments across centres and is recommended for multicenter clinical trials."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The interactive nature of the experimental conditions precluded subject blinding. Independent teams of therapists functioned at each site to deliver the separate treatments, and by necessity were not blinded to treatment." Comment: no blinding but study outcomes unlikely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Quote: "Given the interactive nature of the interventions, patients and treating clinicians could not remain blinded. However, independent evaluators collected the outcome data and were blinded to treatment arm assignment."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "366 subjects consented and were randomized. Five subjects rescinded consent before study procedures began, and 1 withdrew consent later, leaving 360 subjects, 180 in each treatment arm. Data were analysed using an intent‐to‐treat analysis including all randomized patients."
Selective reporting (reporting bias)	Low risk	Quote: "All preplanned and exploratory analyses are reported."
Other bias	Low risk	None identified.

ADL: activities of daily living; FIM: Functional Independence Measure; GCS: Glasgow Coma Score; IADL: Instrumental Activities of Daily Living; SPRS: Psychosocial Reintegration Scale; TASIT: The Awareness of Social Inferences Test; TBI: traumatic brain injury.