| Methods |
RCT of 2 wheelchair cushions with 3‐month follow‐up. Method of randomisation unclear as patients were described as "randomly allocated by the principal investigator". |
| Participants |
Elderly patients (mean age 82 y) in an extended care hospital deemed at high risk of pressure ulcers (Norton Score ≤ 14); sitting in a wheelchair for minimum of 4 consecutive h/day; free of progressive disease likely to confine to bed. Excluded if diabetic, had peripheral vascular disease; confined to bed for more than 120 consecutive h (except if to heal a pressure ulcer).
There were no statistically significant differences between groups at baseline for Norton scores; age; hours in bed/day; sex; diagnosis; sensory loss; history of previous ulcers; weight; nutritional status; oedema; incontinence; hours in wheelchair/day. |
| Interventions |
1. Jay cushion (n = 68); the Jay cushion is a contoured urethane foam base over gel pad.
2. Foam cushion (n = 73); 30 kg/m3 density foam bevelled at the bottom to prevent sling effect.
Both cushions fitted with identical Jay air‐exchange covers of knitted polyester. Patients assigned to their specific wheelchairs by a seating specialist according to a local policy unaffected by the trial. |
| Outcomes |
1. Jay Cushion 25% (17/68);
2. Foam Cushion 41% (30/73).
Pressure ulcer incidence data presented as number of ulcers and number of affected patients for all grades of ulcer, but only as number of ulcers by grade (and there were cases of multiple ulcers on the same patient). Therefore impossible to present the incidence data as number of patients affected by ulcers of grade 2 or above. |
| Notes |
13% attrition; not analysed by ITT. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"Qualified patients were randomly assigned to either foam or Jay cushions in groups of 40 by the principal investigator" Method of randomisation not reported. |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported. |
| Blinding (performance bias and detection bias)
Pressure ulcer incidence |
Low risk |
"The principal investigator was blind to all data" and "A research assistant, an experienced registered nurse (RN), examined the patients weekly, blind, and classified the status of any skin lesions”. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Shown in Table 3. |
| Selective reporting (reporting bias) |
Low risk |
All pre‐specified outcomes reported. |
| Free of other bias ‐ were groups similar at baseline regarding the most important prognostic indicators? |
Low risk |
"No statistically significant differences were found between groups". |
| Free of other bias ‐ was the timing of the outcome assessment similar in all groups? |
Low risk |
Weekly for 3 months. |
