Edmans 2000

Methods	Setting: hospital (Nottingham Stroke Unit) Sites: 1 Countries: UK Trial design: parallel Recruitment dates: May 1992 to July 1994 (excluding February and March 1994 when occupational therapist was unwell)
Participants	Numbers: 80 randomised, 79 analysed (1 died before completion) Definition of stroke: patients on stroke unit after randomisation in trial of stroke unit versus non‐stroke unit care Time since stroke: mean 34 days (range 14 to 84 days) Transfer of training approach (ToT) group: mean 37.7 days (SD 16.6), range 16 to 84, post‐stroke Functional approach group: mean 31.2 days (SD 10.1), range 14 to 56, post‐stroke Since start of rehabilitation: 2 weeks Comorbidities affecting disability ‐ Reported: no Excluded: patients unable to be assessed on the RPAB; participants with insufficient use of one hand to complete RPAB and complete the test tasks; patients unable to transfer with 2 nurses or fewer; patients with a planned discharge date; patients unable to do 2 or more activity of daily living tasks Tools used to define perceptual disorders: RPAB Severity of perceptual disorders: 4 or more low scores (> 2 SDs below mean) from 16 tests Included visuospatial neglect: yes If ‘yes’, frequency/severity: 42 participants (53%) Mean age: overall 69 years; ToT group mean (SD) 70 years (9.1), range 47 to 84 years; FA group mean (SD) 68 years (11.4), range 26 to 86 years Sex: overall 40 (50%) male; ToT group 18 (45%) male; FA group 22 (55%) male Race/ethnicity: not specified
Interventions	Described adequately to replicate: no; the published paper reports that further details are to be published in a later article, but no such article has been identified Broad class: 2 types compared with each other: sensory stimulation (termed by the authors "Transfer of training") and functional training (termed "Functional approach") Specific nature: Transfer of training involved patients practicing particular perceptual tasks in order to produce improvement on tasks with similar perceptual elements, i.e. the cause is treated. For example, patients with difficulty dressing due to spatial relations problems are allowed to practise a spatial task such as cube copying with the expectation that this will produce functional improvement in dressing The Functional approach involved patients repeatedly practicing everyday tasks (usually activities of daily living, such as dressing), i.e. the symptom is treated. So, by practicing dressing the patient will learn to dress, but the expectation is that the underlying perceptual problems remain The authors acknowledge that the basic strategies used in treatment were similar for both groups Frequency: 2.5 hours per week (5 x 30 minute sessions) Duration (from first to last treatment): 6 weeks Profession of 'therapist': occupational therapists (research OT and ward‐based OT) Co‐interventions reported: additional general occupational therapy treatment Excluded: no
Outcomes	Reported: 6‐month ADL: no End of intervention ADL: yes 6‐month perception impairment: no End of intervention perception impairment: yes 6‐month QoL: no 6‐month effect on carer: no Discharge destination: no Adverse events: Death: yes Others: no Fatigue: no Falls: no Accidents: no Others: no Specified primary outcome(s): 5 'main outcomes': RPAB, Barthel ADL and Edmans ADL, with each ADL scale assessed by both nurses and therapists Time points for outcomes: end of intervention (6 weeks) Total number of outcomes: 25 reported; length of stay, number of appointments and total duration of treatment, total scores on RPAB, Barthel (2 assessments), Edmans ADL (2 assessments), RMA gross function score, 16 subtests of RPAB Possible ceiling/floor effects: yes (e.g. ceiling in Barthel, floor in RMA) Assessed by: third party, independent assessor (in discussion with nurses, and separate assessment by ward therapist for ADL measures)
Notes	Personal communication and primary data provided by Dr Edmans
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Random number tables
Allocation concealment?	Low risk	Personal communication. Dr Edmans prepared sequentially numbered, sealed envelopes, opened at recruitment with witness. Not adequate in that researcher prepared list, but assessed as low risk of bias from assurance of inability to remember sequence
Blinding? All outcomes	High risk	Intended independent assessor for outcomes covered by this review, but not reported success
Incomplete outcome data addressed? All outcomes	Low risk	No withdrawals and only one (1%) death
Free of selective reporting?	Low risk	Outcomes described at both impairment and disability levels, and reported in equal detail regardless of statistical significance
Free of other bias?	Low risk