Jiang 2014.
Study characteristics | ||
Methods |
Study objective: to investigate the efficacy of static low‐air‐loss mattress (static LALM) and power pressure air mattress (PPAM) in prevention of pressure ulcers Study design: randomised controlled trial Study grouping: parallel group Duration of follow‐up: 5 days after surgery Number of arms: 2 Single centre or multi‐site: multi‐site Study start date and end date: not described Setting: hospitals |
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Participants |
Baseline characteristics Inclusion criteria: age ≥ 18 years, male or female with Braden score ≤ 16 points, general anaesthesia for surgery with operating time ≥ 120 min, admitted to the intensive care unit (ICU) or surgical wards after surgery, clear consciousness, able to express their feelings correctly, had contraindications for using air mattress (doctor’s orders: lying on hard‐bed or flat‐bed), completed informed consent and related information Exclusion criteria: refused to participate in research; in critical condition and repositioning limited by doctor’s orders; using ice blanket; shed from intervention less than 72 hours; unable to determine the efficacy; incomplete data on the efficacy; or safety judgment. Sex (M:F): overall 621:453 Age (years): overall mean 57.94 (SD 15.54) years (range 18 to 88) Baseline skin status: overall mean Braden scores 13.15 (SD 2.25) (range 6 to 17) Group difference: no difference Total number of participants: n = 1074 Unit of analysis: individuals Unit of randomisation (per patient): individuals |
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Interventions |
Intervention characteristics Static air mattress
Dynamic air mattress
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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
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "We used a random number table to randomize and parallel control design" Comment: low risk of bias because the sequence generation process is proper. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
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 | Low risk | Outcome group: ulcer incidence Comment: low risk of bias because intention‐to‐treat (ITT) analysis performed. Outcome group: comfort Comment: unclear risk of bias because the rates of missing data in both groups are between 10% to 20%. |
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. |