Methods | RCT, multicentre study, parallel group design Random assignment list created before start of trial, independent person used the list to assign people to the 2 groups after recruitment Approach: learning of compensatory strategies |
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Participants | Netherlands, recruited from 8 rehabilitation centres Total participant sample 37: 2 lost at post‐treatment assessment, another 1 at 3‐month follow‐up Treatment group: n = 20; mean age 49.5 ± 8 years; 45% males; 19.3 ± 29.6 months since onset Control group: n = 17; mean age 53.9 ± 11.1 years; 71% males; 6.9 ± 5.4 months since onset No data for hemisphere of lesion, and aetiology Inclusion criteria: stroke > 3 months; referred for cognitive rehabilitation for mental slowness Exclusion criteria: aged < 18 years; stroke < 3 months; severe or disabling premorbid or current (continuing) pathological conditions; severe cognitive, communication, physical, or psychological problems that the person was unable to perform the tasks, based on the clinical judgement of the treating team |
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Interventions | Treatment: 10‐hour teaching in time pressure management session duration varied between 1 and 2 hours a week depending on the individual person Control: care as usual |
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Outcomes | Measured after intervention (time not explicitly specified, but likely to be around 5 weeks) and at 3‐month follow‐up Primary outcomes:
Secondary outcomes:
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Notes | People with stroke were relatively young and ADL‐independent. Control group were more recent after onset. Additional data for analysis provided by the authors | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Random assignment list" was used, no details given |
Allocation concealment (selection bias) | Low risk | After selection of participants independent person used random list to assign people to groups |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and therapist not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessment by blinded research assistant. Analyses showed that assistant had guessed the allocation correctly in 24 of 37 cases (Cohen k = 0.29, P value = 0.05) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across intervention groups |
Selective reporting (reporting bias) | Low risk | No indication in article, but study protocol not available |
ADL: activities of daily living; APT: attention process training; CT: computerised tomography; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; FIM: Functional Independence Measure; GHQ: general health questionnaire; ISI: inter‐stimulus interval; IVA‐CPT: Integrated Visual and Auditory Continuous Performance Test; MRI: magnetic resonance imaging; MMSE: Mini‐mental state examination; PASAT: Paced Auditory Serial Addition Test; PET: positron emission tomography; RCT: randomised controlled trial; SD: standard deviation; SF: Short Form; TBI: traumatic brain injury; WAIS: Wechsler Adult Intelligence Scale; WHO: World Health Organization