Grindley 1996.
Study characteristics | ||
Methods |
Study objective: to compare the performance of the Nimbus II and the Pegasus Airwave mattresses in a hospice setting Study design: randomised controlled trial Study grouping: cross‐over design Duration of follow‐up: 3 days (the first stage of the cross‐over trial) Number of arms: 2 Single centre or multi‐site: single centre Study start date and end date: not described Setting: hospice |
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Participants |
Baseline characteristics Inclusion criteria: patients with existing pressure sores grade 2* or above or patients without existing pressure sores but at high or very high risk of developing pressure sores (Waterlow risk assessment score of 15 or above); minimum anticipated hospice stay of 7 days; patients spending more than 6 hours in a 24‐hour period on the mattress; patients must give consent Exclusion criteria: mental frailty; existing inpatients already on either of the study mattresses; gross obesity (greater than 30 stones, 190 kg); extreme emaciation (less than 6 stones, 38 kg); unstable spinal metastases Sex (M:F): overall 8:12 Age (years): overall mean 69.05 (SD 14.32) Baseline skin status: overall median Waterlow 22.5 (range 15 to 30) mean 22.65 (SD 4.43); 8 with existing ulcers Group difference: not given Total number of participants: n = 20 Unit of analysis: individuals Unit of randomisation (per patient): individuals |
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Interventions |
Intervention characteristics Nimbus II mattress
Pegasus Airwave
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Outcomes |
Proportion of participants developing a new pressure ulcer
Time to pressure ulcer development
Support‐surface‐associated patient comfort
All reported adverse events using allocated support surfaces
Health‐related quality of life (HRQOL)
Cost‐effectiveness
Outcomes that are not considered in this review but reported in trials:
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Notes | Challenging to contact the study authors to request data at the first stage of this cross‐over trial. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed using a random numbers table" Comment: low risk of bias because the sequence generation process is proper. |
Allocation concealment (selection bias) | Low risk | Quote: "To avoid bias, the order in which the mattresses were allocated was randomised and selected by the investigator from sealed opaque envelopes in sequential order." Comment: low risk of bias because it is likely to conceal allocation properly. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: no information provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Outcome group: comfort Quote: "mattress preference questionnaire completed by 16 patients" Comment: unclear risk of bias because no information given on which group the missing are from. |
Selective reporting (reporting bias) | Low risk | Comment: the study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified. |
Other bias | Low risk | Comment: the study appears to be free of other sources of bias. |