Whitney 1984.
| Study characteristics | ||
| Methods |
Study objective: to provide data that will assist nurses in determining which mattress is the best choice for pressure sore prevention, and under which circumstances Study design: randomised controlled trial Study grouping: parallel group Duration of follow‐up: the average length of study 8.9 days in alternating pressure mattress; 7.6 in foam mattress Number of arms: 2 Single centre or multi‐sites: single centre Study start date and end date: not described Setting: medical‐surgical unit |
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| Participants |
Baseline characteristics Inclusion criteria: patients on 3 medical‐surgical units who were in bed for 20 out of 24 hours daily Exclusion criteria: not described Sex (M:F): not described Age (years): mean 63.2 (range 19 to 91) Baseline skin status: people with ulcers included (2 had serious decubiti on admission, 1 in each of the groups) Group difference: not reported Total number of participants: n = 51 Unit of analysis: individuals Unit of randomisation (per patient): individuals |
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| Interventions |
Intervention characteristics Alternating pressure mattress
Foam mattress
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| Outcomes |
Proportion of participants developing a new pressure ulcer
Time to pressure ulcer incidence
Support‐surface‐associated patient comfort
All reported adverse events of using allocated support surfaces
Health‐related quality of life (HRQOL)
Cost‐effectiveness
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "26 were selected at random and placed in the foam mattress group, 25 in the AP mattress group" Comment: unclear risk of bias because it is unclear how random sequence was generated. |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk |
Outcome group: primary outcome Quote: "... the investigators, who assessed the patient and placed him/her in one of the two mattress groups" Comment: high risk of bias because it is likely the investigators, i.e. key study personnel who operated the study, were not blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk |
Outcome group: primary outcome Quote: "In most cases patients were assessed by two investigators as a team, and occasionally by only one of the investigators" Quote: "The investigators who rated patient risk and evaluated skin condition knew the mattress assignment of each patient, making investigator bias possible" Comment: high risk of bias because non‐blinding of outcome assessment is clearly stated. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no information provided. |
| Selective reporting (reporting bias) | Unclear risk | Comment: no information provided. |
| Other bias | Unclear risk | Comment: no information provided. |