Stapleton 1986.
| Methods | Quasi RCT: allocation by means of alternation. Duration of follow‐up unclear. | |
| Participants | Female elderly patients with fractured neck of femur, without existing pressure ulcers, Norton score 14 or less. Baseline data presented and groups well matched for age and Norton score. | |
| Interventions | 1. Large Cell Ripple (Talley) (n = 32). 2. Polyether foam pad 2 feet x 2 feet x 3‐inch thickness (n = 34). 3. Spenco pad (n = 34). | |
| Outcomes | Ulcers of grade 2 or greater:
1. Large Cell Ripple: 34% (11/32);
2. Polyether foam pad: 41% (14/34);
3. Spenco pad: 35% (12/34). Grade 3 and greater: 1. Large Cell Ripple: 0% (0/32); 2. Foam pad: 24% (8/34); 3. Spenco pad: 6% (2/34). |
|
| Notes | 45 Large Cell Ripple mattresses required 50 motor repairs and 90 material repairs during 12‐ month study. Patients did not like the feel of the ripples. No mention of withdrawals. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation for first 2 groups, but not for subsequent groups: “patients for the first two groups were selected by lottery, and thereafter patients were allocated to each group systematically, in rotation”; total numbers for the first 2 groups were not reported. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Blinding (performance bias and detection bias) Pressure ulcer incidence | Unclear risk | Not reported. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Out of 100 patients recruited, “two patients allocated to the Ripple pad were lost to ward transfer”. |
| Selective reporting (reporting bias) | Unclear risk | Outcomes not pre‐specified. |
| Free of other bias ‐ were groups similar at baseline regarding the most important prognostic indicators? | Low risk | No baseline differences on mean age and Norton scores (the presence of existing pressure ulcers was an exclusion criterion for the study). |
| Free of other bias ‐ was the timing of the outcome assessment similar in all groups? | Unclear risk | Inclusion criteria stated female patients only. |