Skidmore 2015a.

Study characteristics
Methods	Design: parallel RCT Duration of trial: not reported Unit of randomisation: inpatient adults with a clinically defined stroke and confirmed cognitive impairment Recruitment and allocation: consecutive inpatient admissions of adults with cognitive impairments after acute stroke were invited to participate, with 60 inpatients assessed for eligibility. 27 did not meet eligibility criteria and 3 withdrew, leaving 30 that were randomised by random number table to 2 intervention groups, strategy training (IG) (n = 15) and attention control (CG) (n = 15).
Participants	Setting: metropolitan university medical centre rehabilitation facility Country: USA Sample size: 30 adults, 67% men; IG: 15; CG: 15 Exclusions: primary diagnosis of acute stroke; no impairment of cognitive functions (Quick Executive Interview ≤ 3); presence of severe aphasia (Boston Diagnostic Aphasia Examination Severity Rating Scale ≥ 1); diagnosis of dementia (indicated in the medical record); presence of current major depressive disorder, bipolar, or psychotic disorder (Primary Care Evaluation of Mental Disorders); presence of drug and alcohol abuse within 3 months (Mini‐International Neuropsychiatric Interview); anticipated length of stay < 5 days Age: mean: IG: 64.87 (SD 16.59) years; CG: 71.80 (SD 13.19) years Time since stroke onset: mean: IG: 16.80 (SD 15.58) days; CG: 18.47 (SD 21.29) days Types of stroke: ischaemic, n: IG: 10 (67%); CG: 11 (73%) Hemisphere: right, n: IG: 10 (67%); CG: 10 (67%) NIHSS stroke severity: mean: IG: 8.87 (SD 2.77); CG: 5.87 (SD 2.72)
Interventions	Intervention group Brief name: strategy training Recipients: inpatient adults with cognitive impairments after acute stroke Why: to harness the ability of the person with cognitive impairments after stroke to observe, assess, and positively alter his or her performance in real‐life activities; to teach participants to identify and prioritise problematic daily activities, identify barriers impeding performance, generate and evaluate strategies addressing these barriers, and generalise learning through practice. What (materials): workbook materials, COPM (Law 1998), modified CO‐OP manual (Polatajko 2004) for adults with TBI (Dawson 2009), "Goal‐Plan‐Do‐Check" goal sheets (see Appendix 1 of Dawson 2009) What (procedures): sessions were administered according to standardised procedures described further in Dawson 2009, Skidmore 2011, and Skidmore 2014. 4 critical ingredients (self‐selected goals, self‐evaluation of performance, strategy development and implementation, and therapeutic guided discovery) were applied iteratively throughout the sessions in 4 steps via guided discussion and workbook materials. Self‐selected goals: using the COPM and indepth interviews over 1 or 2 sessions, therapists helped participants identify activities that were important to them and that were difficult to perform since the stroke. After prioritising these activities, the participants chose 4–6 activities to address. Self‐evaluation: the participants selected an activity, performed that activity, and identified barriers to performance. Strategy development: participants learned a global "Goal‐Plan‐Do‐Check" strategy where they set a goal to address identified barriers (i.e. set criterion for performance outcome), developed a plan to address the goal, completed the plan, and checked whether the plan worked or required revising. Generalisation and transfer: these steps were repeated iteratively until the goal was met (and thus participants moved on to the next activity). Using guided discovery technique, the therapists prompted the participants to identify key principles that they learned and to discuss ways to apply these key principles. Who provided: trained rehabilitation personnel, including occupational therapists How: face‐to‐face guided discussion sessions Where: inpatient rehabilitation facility When and how much: 45‐minute sessions daily 5 days per week for the duration of inpatient rehabilitation (in addition to usual inpatient rehabilitation therapy) Tailoring: participants self‐selected their goals and prioritised and choose 4–6 activities to address in the sessions; steps were repeated iteratively until the goal was met (and thus participants moved on to the next activity). Using guided discovery technique, the therapists prompted the participants to identify key principles that they learned and to discuss ways to apply these key principles. Modifications: not reported How well (planned): fidelity procedures were completed using a protocol described elsewhere (Skidmore 2014), which reported that "All research intervention sessions were videotaped and rated for fidelity to the respective manualized procedures … [using] fidelity checklists …  to assess treatment integrity and treatment differentiation in a random 20% of sessions in each treatment group". How well (actual): there is no report of the outcome of the videotaped fidelity rating, as described above. Comparator group Brief name: attention control Recipients: inpatient adults with cognitive impairments after acute stroke Why: to provide a comparable intervention in addition to usual rehabilitation similar in dose and attention. What (materials): workbook materials, e.g. journal entries and scripted open‐ended questions What (procedures): initial sessions were used to help the participants identify and prioritise self‐selected goals, using same procedure used in the strategy training intervention. "The remaining sessions focused on the use of journal entries in a workbook and discussions using scripted open‐ended questions to stimulate participants' reflections on their rehabilitation goals, activities, and experiences" (p.3). Who provided: trained rehabilitation personnel How: face‐to‐face guided discussion and written materials Where: inpatient rehabilitation facility When and how much: 45‐minute sessions daily, 5 days per week for the duration of inpatient rehabilitation (in addition to usual inpatient rehabilitation therapy) Tailoring: if participants asked direct questions for guidance on addressing their goals, they were directed to the discuss the questions with the rehabilitation team. Modifications: none reported How well (planned): fidelity procedures were completed using a protocol described elsewhere (Skidmore 2014), which reported that "All research intervention sessions were videotaped and rated for fidelity to the respective manualized procedures… [using] fidelity checklists … to assess treatment integrity and treatment differentiation in a random 20% of sessions in each treatment group". How well (actual): there is no report of the outcome of the videotaped fidelity rating, as described above.
Outcomes	Primary FIM Secondary CWIT 3 CWIT 4 Methods of data collection: demographic data and medical information were obtained from medical records at study admission; a battery of outcome measures was administered by trained raters masked to study intent and design. Data collection time points: baseline, 3 months, and 6 months later
Notes	Funding: yes Conflict of interest: none Published trial protocol: no Trial registration: yes, NCT02755805 Ethics approval: "We … obtained written informed consent from the individual, if cognitive status permitted, or from a proxy, consistent with approved institutional review board procedures". Data: we obtained additional mean and standard error data from the Clinical Trials Registry (NCT02755805); we converted standard errors to SDs in Review Manager 5.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Simple randomisation scheme used derived from a random number table (1:1 ratio).
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "… single‐blind study … research intervention sessions were administered according to standardized procedures … by trained rehabilitation personnel who were masked to the opposing intervention protocol".
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Trained and reliable raters who were masked to study intent and design administered a standardized measure of activities of daily living and a battery of neuropsychological tests at baseline, 3 months, and 6 months later".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing data managed appropriately (repeated‐measures mixed modelling, without imputing data) and caution urged for interpretation of results. 20% of participants were missing 6‐month data for the primary outcome due to refusal of assessments (n = 1), withdrawal (n = 2), and loss to follow‐up (n = 3).
Selective reporting (reporting bias)	Low risk	All outcomes from method and protocol reported.
Other bias	Low risk	No other identifiable sources of bias.