Jolley 2004.
Methods | RCT with unclear follow‐up period, mean bed days observed/participant Group 1: 7 days, and Group 2: 7.9 days. | |
Participants | Participants recruited from a single hospital, and had to be at low to moderate risk of developing a pressure ulcer and > 18 y. Patients were excluded if they had no risk or high risk (as more complex interventions required), if they had any pre‐existing ulcers, had an expected length of stay of < 48 h or had darkly‐pigmented skin (justified by authors as making grade 1 ulcers difficult to detect). Participants well matched at baseline for age, sex, mean pressure ulcer risk score. |
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Interventions | 1. Sheepskin mattress overlay: leather‐backed with a dense, uniform 25 mm wool pile. Used as a partial mattress overlay. Pressure points that were not covered by sheepskin were protected by a second sheepskin, or specific sheepskin elbow and heel protectors. Overlays were changed 3 times a week (unless required). Received usual care including repositioning (n = 270). 2. Usual care as determined by ward staff. Included repositioning and any other PRD or prevention strategy with/without low‐tech constant pressure relieving devices (n = 269). | |
Outcomes | Number of participants with incidence pressure ulcer (daily assessment; unblinded outcome assessment):
All ulcers (grade 1 and 2; no grade 3 or 4 recorded)
1. Sheepskin: 10% (21/218);
2. Usual care: 17% (37/223). Total number of ulcers: 1. Sheepskin: 27; 2. Usual care: 58. Total number of incident grade 2 ulcers: 1. Sheepskin: 12; 2. Usual care: 20. |
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Notes | Whilst 270 were allocated to the sheepskin and 269 to control; only 218 and 223 received their allocated treatment and are included in the analysis. Not ITT. "Any patient whose risk increased to high (Braden score <12) for 48 h was no longer followed up for pressure‐ulcer endpoints." Authors did not say why. Of the 218 participants in the sheepskin group 2 died, 7 became high risk (treatment change), 14 requested withdrawal, 6 had ward staff intervention and 11 changed treatment for other reasons. Of the 223 control participants 5 died, 1 became high risk, 8 requested withdrawal, 5 had ward staff intervention and 10 changed treatments for other reasons. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Shuffling cards(?): "Patients were randomly allocated to receive.......using numbered cards in individually sealed opaque envelopes; blocks of 16 envelopes (eight of each group) were shuffled before use". |
Allocation concealment (selection bias) | Low risk | "Patients were randomly allocated to receive.......using numbered cards in individually sealed opaque envelopes; blocks of 16 envelopes (eight of each group) were shuffled before use". |
Blinding (performance bias and detection bias) Pressure ulcer incidence | High risk | "As it was logistically impossible to blind patients, ward staff and research nurses to the treatment group this was an open‐label, unblinded trial". |
Incomplete outcome data (attrition bias) All outcomes | High risk | "539....were randomly allocated. Of these, 441 received the allocated intervention. All 441 were followed up to the endpoints...". Data for 441 not 539. Is a per protocol analysis. |
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 | Baseline data for 441 participants and not the 539 randomised. |
Free of other bias ‐ was the timing of the outcome assessment similar in all groups? | Low risk | "Research nurse assessed each participant daily for pressure ulcer risk.....and skin integrity". |