Daechsel 1985.
Study characteristics | ||
Methods |
Study objective: to assess 2 commonly used special mattresses in a randomised trial involving adult non‐geriatric chronic neurologic patients Study design: randomised controlled trial Study grouping: parallel group Duration of follow‐up: 3 months Number of arms: 2 Single centre or multi‐sites: single centre Study start date and end date: not described Setting: long‐term care hospital for chronic neurologic conditions |
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Participants |
Baseline characteristics Inclusion criteria: consenting patients in a long‐term care hospital for chronic neurologic conditions ... a) between 19 and 60 years of age, b) free of any evidence of skin breakdown two weeks prior to the study, and c) considered to be at high risk of developing pressure ulcers based on assessments conducted by the ward team [Norton scale score of 14 or less; and clinical judgement] Exclusion criteria: none Sex (M:F): 10:6 in alternating air mattress; 6:10 in Silicore mattress Age (years): mean 42.6 (SD 13.7) in alternating air mattress; 38.5 (13.82) in Silicore mattress Baseline skin status: mean Norton score 13.35 (SD 1.86) in alternating air mattress; 12.97 (2.28) in Silicore mattress. Group difference: no difference Total number of participants: 32 Unit of analysis: individuals Unit of randomisation (per patient): individuals |
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Interventions |
Intervention characteristics Alternating air mattress
Silicore 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 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 | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "All were randomly assigned to one of the two types of mattresses" Comment: the method of randomisation was not described. |
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 Comment: no information provided. |
Blinding of outcome assessment (detection bias) All outcomes | High risk |
Outcome group: primary outcome Quote: "one of the investigators (DD) conducted weekly skin checks of the subjects" Comment: high risk of bias for pressure ulcer incidence outcome because it is unlikely that the investigator who assessed skin conditions was blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk |
Outcome group: primary outcome Quote: "Thirty‐two patients met the criteria for this study ... all admitted to the trial and completed it" Comment: no missing data. |
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. |