Nakagami 2007.
Methods |
Trial design: RCT Trial grouping: within‐participant (participant acting as their own control) Ethics and informed consent: yes Follow‐up period: 3 weeks Sample size estimate: yes, the estimated sample size was 33, and therefore 37 participants were enrolled, assuming a loss to follow‐up of 10% ITT analysis: yes; number randomised: 37; number analysed: 37 Funding: this study was supported by a Grant‐in‐Aid for scientific research from the Ministry of Education, Culture, Sports, Science and Technology, Japan [(B) (2) 16390637] |
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Participants |
Inclusion criteria:
Exclusion criteria:
Pretreatment
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Interventions |
Intervention group:
Control group:
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Outcomes |
PU incidence
Incidence of persistent erythema
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Identification |
Sponsorship source: not stated Country: Japan Setting: 500‐bed geriatric hospital Comments: no comments Author's name: G Najagami Institution: Division of Health Sciences and Nursing, Graduate School of Medicine Email: not provided Address: University of Tokyo, Tokyo, Japan |
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Notes | PU classification system not clearly described | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded, quote: “impossible due to the type of intervention” |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not blinded, quote: "test area outlined so that the dressing applied back to the same area" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT conducted |
Selective reporting (reporting bias) | Low risk | All outcomes reported in the paper were those outlined by the study authors |
Other bias | High risk | Investigators were part of the group that developed the PPD |