Cobb 1997.
Methods | RCT with 40‐day follow‐up. | |
Participants | Recruitment in hospital wards and intensive care units. Participants > 18 y of age, ≤ 290 pounds, without pre‐existing pressure ulcer, an expected length of stay of 1‐2 weeks and considered at “high risk” on the basis of the Braden Scale. Patients allocated through the selection of a treatment card by an independent nurse. Some baseline imbalance observed with older participants; more participants with co‐morbidities in the KinAir group. | |
Interventions | 1. Low loss air bed (KinAir Bed) (n = 62). 2. Static air mattress overlay (EHOB waffle) (n = 61). | |
Outcomes | Number of participants with incidence pressure ulcer (ICU participants assessed daily, ward patients assessed every 48 h):
Grade 1
1. KinAir Bed 5% (3/62);
2. EHOB waffle 2% (1/61). Grade 2. 1. KinAir Bed 5% (3/62); 2. EHOB waffle 18% (11/61) Eschar 1. KinAir Bed 3% (2/62); 2. EHOB waffle 0/61. |
|
Notes | No higher grades reported. No loss to follow‐up reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were placed into one of the study groups by random selection of a treatment card". Method of randomisation unclear. |
Allocation concealment (selection bias) | Low risk | The use of an independent nurse picking a treatment card. |
Blinding (performance bias and detection bias) Pressure ulcer incidence | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No numbers/reasons given for exclusions/attrition. |
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? | High risk | EHOB waffle group had more participants in younger age bracket; KinAir group had more with diabetes and cancer. |
Free of other bias ‐ was the timing of the outcome assessment similar in all groups? | High risk | "Patients in the ICUs had skin assessments daily and those on the wards were assessed every 48 hours". |