| Methods |
RCT with 1‐month follow‐up. Allocation by random‐number table. |
| Participants |
Inclusion criteria: > 65 y, inpatients, with a Braden Score of ≤16. Age ranged from 65‐98 y, 58 women, 26 men. Recruited from general medicine, acute geriatric medicine and long term care. All patients free from pressure ulcers on admission.
Groups similar for important variables at baseline. |
| Interventions |
1. Convoluted foam overlay (CF), 3 or 4 inches thick (n = 45).
2. Solid foam overlay (SF) 4 inches thick, sculptured (n = 39). |
| Outcomes |
Incidence of pressure ulcers assessed by Research Nurse presumably not blinded to intervention.
Included grade 1 ulcers:
CF: 47%;
SF: 31%. |
| Notes |
All patients appear to have completed the study. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"..a random number table was used to assign study participants to...." |
| Allocation concealment (selection bias) |
Unclear risk |
not clearly reported |
| Blinding (performance bias and detection bias)
Pressure ulcer incidence |
Unclear risk |
not clearly reported |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
"..45 patients were assigned to the CF group and 39 to the SF group......"
"...33 (39%) patients developed a total of 57 pressure ulcers...." |
| 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? |
Unclear risk |
Similar for Braden score, age, mobility, but these figures were not presented for all those randomised. Treatment group were lighter, 118.51 lb vs 129.46 lb when all participants included. |
| Free of other bias ‐ was the timing of the outcome assessment similar in all groups? |
Low risk |
"Research nurses assessed each patient’s skin and completed a Braden scale every Monday, Wednesday and Friday for 1 month or until discharge...". |
