Price 1999.
Methods | RCT with follow‐up 14 days postoperatively. | |
Participants | Patients with fractured neck of femur and Medley score of > 25 (very high risk), aged over 60 y. | |
Interventions | 1. Repose system (low‐pressure inflatable mattress and cushion in polyurethane material) (n = 40). 2. Nimbus III dynamic flotation plus TransCell cushion (n = 40): all other care standard best practice, including regular repositioning. | |
Outcomes | 1. Repose system: at admission 14/40 has pressure ulcers; preoperatively, 7/36; at 7 days: 6/32; at 14 days: 5/24. 2. Nimbus III: at admission had pressure ulcers, 13/40; preoperatively, 8/37; at 7 days: 5/31; at 14 days: 4/26. | |
Notes | 80 patients randomised; 50 featured in final analysis (assessed 14 days post‐operatively) i.e. 38% attrition. Patients with pressure ulcers recruited. Difficult to ascertain how many of those with existing pressure ulcer included in 7‐day and 14‐day follow up assessments (see Table 4 of paper) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Stated, "a concealed computer‐generated list was used to randomise eligible consecutive consenting patients to one of the support systems". |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) Pressure ulcer incidence | High risk | “Patients were not assessed blindly as it was considered that displacement for examination would cause excessive discomfort”. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | “No patient was excluded from the analyses. In many patients the data were incomplete, but they have been included in the analyses for those time points where data are present”; data from 50 (out of 80 patients) only analysed for final assessment. |
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 on prognostic indicators at baseline between groups. |
Free of other bias ‐ was the timing of the outcome assessment similar in all groups? | Low risk | No other concerns. |