Evans 1988.
| Methods | Allocation by method of Taves (minimisation) Blinded outcome assessment 13 patients and carers (6 treatment, 7 control) lost to follow‐up 6‐month and 1‐year follow‐up |
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| Participants | Seattle, WA, USA 140 stroke patients and carers (majority couples) recruited: treatment N = 70; control N = 70; completed final follow‐up: N = 127 Mean age of patient: treatment 63 years; control 62 years Sex of patient male: treatment 95%; control 94% Inclusion criteria: all stroke patients on inpatient wards from any referring service, hospitalised primarily for stroke, living with primary caregiver Exclusion criteria: none stated |
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| Interventions | Treatment: 2 classes: (1) lecture and video 'Living with stroke', followed specific outline of information developed by psychiatrists, included basic information about the consequences of stroke; (2) explanation of treatment unique to the family's situation and questions Focus: carer Setting: hospital Administration: occupational therapist (class 1), social worker (class 2). 2 x 1‐hour classes during third week of stroke; second class within 3 working days of the first Control: routine care |
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| Outcomes | (1) Knowledge of stroke (6 months and 1 year) (2) Family function (6 months and 1 year) (3) Patient adjustment (6 months and 1 year) (4) Use of social resources (6 months and 1 year) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly assigned to conditions after minimizing the differences for variates known to predict stroke recovery: mood, self‐care ability (Barthel Index), mental status, age, and location of the lesion. The method of Taves[14] was used." |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No information reported. However, as no alternative intervention for control groups, blinding of participants not possible |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No report of blinded assessment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Small numbers lost to follow‐up with similar reasons reported |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not available so cannot assess reporting bias |
| Other bias | Unclear risk | Imbalance in reported baseline conditions (marital status and number in household) may mean choice of minimisation factors was incomplete |