| Methods |
RCT with 14‐day follow‐up. Allocation by random‐number tables; degree of allocation concealment unclear. |
| Participants |
Patients aged > 55 y with hip fracture, with or without pressure ulcers. Excluded: those with a pressure ulcer of grade 3 or 4 at entry.
Patients in each group were well matched for age and Waterlow score at baseline. |
| Interventions |
Results for Group 2 (NHS contract surface ‐ standard foam): 17/64
Results for Groups 1, 3, 4 and 5, alternating foam combined) 42/441 |
| Outcomes |
Rates of removal from study due to skin deterioration:
1. Clinifloat: 9%;
2. NHS contract: 27%;
3. Transfoam: 10%;
4. Therarest: 11%;
5. Vaperm: 8%. |
| Notes |
9% attrition. At interim analysis, Clinifloat and NHS contract mattresses were removed from the study; Clinifloat due to superior performance, and the NHS mattress due to high rates of pressure ulcer development. This explains why there were fewer patients on these surfaces. Omnifoam mattress showed foam collapse after 6 weeks and were withdrawn from use and replaced with Vaperm mattresses. Problems with mattress cover found on 2 Therarest mattresses, 3 Transfoam mattress covers, and 3 times with the Clinifloat mattress. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random‐number tables used. |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported. |
| Blinding (performance bias and detection bias)
Pressure ulcer incidence |
Unclear risk |
Skin assessments undertaken by research nurse; patient unlikely to be removed from mattress for assessment, although not explicitly reported. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Patient removal numbers reported; attrition within reasonable limits (20% of total participants recruited at baseline). |
| 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 |
Mean age and Waterlow scores reported as well‐matched across different mattress groups. |
| Free of other bias ‐ was the timing of the outcome assessment similar in all groups? |
Low risk |
No other concerns. |
