Cicerone 2008.

Methods	Design: prospective, randomized clinical trial. Randomization: 2‐arm, block randomization, with stratification for referral source as either clinical or community. Duration of study: January 2003 to December 2006.
Participants	Number randomized: 68 participants, 34 received the intervention and 34 received control. Inclusion criteria: medical documentation of TBI based on a primary source within 24 hours of injury (e.g. emergency medical services or hospital admission records); ≥ 3 months postinjury; aged 18‐62 years; adequate language expression and comprehension (with or without assistive device) to participate in verbally based group interventions (i.e. participants had to be English speaking and could not be severely aphasic); judged to require ≥ 4 months of comprehensive treatment; clinically appropriate for either arm of treatment; capable of attending treatment 3 days per week; capable of giving informed consent. Exclusion criteria: active psychiatric illness, substance abuse or pain considered at the time of enrolment to prevent their compliance with treatment.
Interventions	Intervention: Intensive Cognitive Rehabilitation Programme Individual and group therapy. Intervention based on principles of comprehensive holistic neuropsychiatric rehabilitation emphasizing the integration of interventions for cognitive deficits, emotional difficulties, interpersonal behaviours and functional skills within the context of a therapeutic environment. Duration: 16 weeks, with 15 hours of therapy 3 days per week, that included 11 hours of group therapy, 3 hours of individual therapy and 1 hour of individual neuropsychological treatment. Control: standard neurorehabilitation. Predominantly individual therapy. Comprehensive interdisciplinary day treatment programme, consisted of physical occupational and speech therapies, along with neuropsychological treatment. Duration: 16 weeks. Amount and combination of specific treatments for each participant in the standard neurorehabilitation programme condition varied based on person's needs and routine clinical decision making, but group treatments were limited to no more than 3 hours per week.
Outcomes	Community Integration Questionnaire (CIQ) and Perceived Quality of Life (PQOL) scale. Vocational and educational outcomes measured by Vocational Integration Scale, ratings of which were collapsed into a dichotomous variable to classify participants as either engaged in community‐based employment (Vocational Integration Scale levels 3‐5) or unemployed (Vocational Integration Scale levels 1‐2). Other secondary outcome measures were neuropsychological functioning and perceived self‐efficacy.
Notes	Setting: Department of Cognitive Rehabilitation and Department of Physical Medicine and Rehabilitation, JFK‐Johnson Rehabilitation Institute, Edison, New Jersey. Country: US. Duration of follow‐up: 6 months. Dropouts: of the 34 allocated to each arm, 2 from the intervention group and 4 from the control group did not complete the protocol. On completion of the protocols, 2 from each arm did not respond to requests for 6‐month follow‐up evaluation. Funding: National Institute on Disability and Rehabilitation Research.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was conducted through the web‐based interactive statistical calculation pages," "randomisation occurred in unequal blocked multiples of 4."
Allocation concealment (selection bias)	Low risk	Quote: "The allocation of participants to treatment condition was concealed by placing the individual randomized assignments in sequentially numbered, opaque, sealed envelopes."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "participants and therapists had knowledge that both treatments were clinically established programs that were expected to be beneficial, with no assumption regarding differential benefits and no further information about the specific intent of the study."
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Quote: "Data entry and scoring for these measures were conducted by a research assistant who was blind to treatment condition."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dropouts reported, 2 in each arm, and included in the final analysis.
Selective reporting (reporting bias)	Low risk	Published report contained all expected outcomes including subgroup analysis of certain outcome measures.
Other bias	Low risk	None identified.