Andersen 1982.
Study characteristics | ||
Methods |
Study objective: to observe "the development of pressure sores in risk‐patients nursed on these mattresses [water‐mattresses and alternating pressure air‐mattresses and compare] the results with a similar group of patients nursed on ordinary hospital mattresses" Study design: randomised controlled trial Study grouping: parallel group Duration of follow‐up: 10 days Number of arms: 3 Single centre or multi‐site: single centre Study start date and end date: not described Setting: hospital |
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Participants |
Baseline characteristics Inclusion criteria: patients with acute conditions and a risk score of 2 or more (i.e. at risk) Exclusion criteria: "those who already had pressure sores" Sex (M:F): 60:101 in control; 73:93 in air; 73:82 in water Age (years): distribution of participants' ages described Baseline skin status: all at risk according to the risk score used by the authors; free of ulcers Group difference: no difference between groups according to age, sex, body weight or risk score Total number of participants: not described; n = 482 available Unit of analysis: individuals Unit of randomisation (per patient): individuals |
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Interventions |
Intervention characteristics Alternating‐pressure air‐mattress
Water mattress
Ordinary hospital mattresses
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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: 1. "opinions on mattresses" described as "the acceptability of the mattress" and rated as the numbers of staff satisfied and the numbers of patients satisfied with different mattresses. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Six hundred patients at risk for pressure sores were randomised in either a control group or one of two experimental groups ... They were allotted to one of the three groups ..." Comment: method of randomisation was not reported |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk |
Outcome group: primary outcome (i.e. the only outcome) Comment: no information provided |
Blinding of outcome assessment (detection bias) All outcomes | High risk |
Outcome group: primary outcome (i.e. the only outcome) Quote: "One of us [note: study's authors] assessed the condition of the skin ..." Comment: appears to have no blinding, and the pressure ulcer incidence outcome measurement is likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk |
Outcome group: primary outcome (i.e. the only outcome) Quote: "Six hundred patients at risk for pressure sores were randomised ..." Quote: "Among the 600 risk‐patients ... 118 dropped out during the first 24 hours before the first dermatologic inspection. This did not impair randomization." Quote: "The groups remained comparable throughout the 10‐day study period" Comment: unclear risk of bias was judged because authors claimed that randomisation was not impaired though the proportion of missing data was high and no reasons for missing data were provided. |
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. |