Salazar 2000.

Methods	Design: single‐centre, parallel group, randomized trial (not blinded). Randomization: 2‐arm parallel group. Duration of study: January 1992 to February 1997.
Participants	Number randomized: 120 participants randomized. 67 assigned to intervention and 53 to control using blocked randomization by an independent study statistician. Inclusion criteria: moderate‐to‐severe closed head injury manifested by GCS score of ≤ 13 or posttraumatic amnesia of ≥ 24 hours or focal cerebral contusion or haemorrhage on computerized tomography or magnetic resonance imaging; head injury within 3 months of randomization; Rancho Los Amigos scale stage 7; active duty military personnel; accompanied home setting with ≥ 1 responsible adult available; ability to ambulate independently; no prior severe TBI or other severe disability. Exclusion criteria: people with mild TBI.
Interventions	Intervention: in‐hospital rehabilitation. Physical fitness training and group and individual cognitive, speech, occupational and coping skills therapies. Specific group therapies were planning and organization, cognitive skills, pragmatic speech, milieu, psychotherapy and community re‐entry. Duration: 8 weeks of standardized, protocol‐defined structured daily routine. Control: home rehabilitation. TBI education and individual counselling from a psychiatric nurse. Education materials were given and strategies recommended for enhancing cognitive and organizational skills. They were trained in various number and card game exercises, were encouraged to watch news programmes and read magazines and books. Duration: 8 weeks. Weekly 30‐minutes telephone call from the psychiatric nurse inquiring about the week's events and offering support and advice in addressing problems. Daily physical exercises at own pace.
Outcomes	Return to work and fitness for military duty at 1‐year post‐treatment as determined by interview, military records or both. 'Work' defined as either full time (≥ 35 hours per week) or part time (≤ 35 hours per week) gainful military or civilian employment. 'Fitness for duty' included all people who were still on active military duty or had received a normal discharge from service but excluded people who had a medical discharge or whose discharge was pending.
Notes	Setting: Walter Reed Army Medical Center (WRAMC), Washington, DC. Country: US. Duration of follow‐up: 24 months. Dropout: 7 withdrew from hospital rehabilitation (2 medical reasons, 5 voluntary non‐medical); 6 from home rehabilitation group received supplemental therapy and were excluded. Funding: Defense and Veterans Head Injury Program and Medical Research Service of the Department of Veterans Affairs.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Blocked randomisation was done by an independent study statistician using variable‐sized blocks to prevent investigators from guessing the code."
Allocation concealment (selection bias)	Low risk	Quote: "Blocked randomisation was done by an independent study statistician using variable‐sized blocks to prevent investigators from guessing the code."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Programs were implemented by separate teams of therapists who generally functioned independently of each other and of the outcome evaluation personnel, although complete blinding was not possible." 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: "Programs were implemented by separate teams of therapists who generally functioned independently of each other and of the outcome evaluation personnel, although complete blinding was not possible." Comment: no blinding but study outcomes unlikely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Seven patients failed to complete the full hospital program, 2 for medical reasons and 5 who voluntarily withdrew an average of 3 weeks into the program. Likewise, 6 patients in the home treatment group required supplemental therapy because of persistent behavioural or mood problems, 4 of them after completing the home program. All these randomized patients were included in the principal intent‐to‐treat analysis. However, excluding them from repeat analysis did not change the results substantially."
Selective reporting (reporting bias)	Low risk	Quote: "Forty‐seven eligible patients who refused to participation were similar to the 120 study participants in demographics, injury severity, and clinical status at study entry. Data were analysed using the intent‐to‐treat analysis that included all randomized patients."
Other bias	Low risk	Comment: no additional biases detected.