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. 2023 Jul 28;2023(7):CD007546. doi: 10.1002/14651858.CD007546.pub3

Dever Fitzgerald 2016.

Study characteristics
Methods Study design: randomised controlled trial (not registered, no study protocol published)
Intervention period: not clearly reported
Duration of follow‐up: 8 months (4 months baseline period, follow‐up data were collected 4 months after the end of the baseline period)
Study period: not reported
Participants Country: Canada
Setting: recruited from 26 different nursing homes (no further information reported)
Participants:
  • Inclusion criteria: nursing home residents with a diagnosis of dementia who were ambulatory within the facility

  • Number of participants randomised: not reported

  • Number of participants lost to follow‐up: 26 (17%), information from study authors: intervention group 14, control group 10, (two participants were lost to follow‐up before randomisation), n = 22 died, n = 4 other reasons not specified (not reported separately per group)

  • Number of participants completing the study: 150; intervention group: 77, control group 73


Baseline characteristics:
  • Age (mean ± SD), 86.22 ± 6.41 years

  • Gender, female: 70%

  • Cognitive status (cognitive performance scale, mean ± SD): 3.44 ± 1.16

  • Care dependency (Older American resource and services Activity of Daily Living Questionnaire, mean ± SD): intervention group 1: 9.08 ± 2.45; control group: 8.43 ± 3.22

Interventions Intervention: fall risk assessment (providing information about residents' fall risk to nursing staff)
Control: usual care
Outcomes No primary outcome defined
  • Use of physical restraints

  • Fall risk

Notes Funding: partly funded through a grant from the Saskatchewan Health Research Foundation
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Participants were randomly assigned to the control or experimental groups". No further information provided
Personal communication with study authors: "Each participant was assigned to the control vs. experimental group via coin toss."
Allocation concealment (selection bias) High risk No information reported
Personal communication with study authors: "No specific method/effort to conceal allocation was used."
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding of personnel was not possible as the same nurses cared for participants in both study groups and there was a risk of contamination.
Although no pressure sensors were available for the participants allocated to the control group, a performance bias might be present.
Personal communication with study authors: The participants were informed about the study, but the intervention was delivered to the nursing staff.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Outcome assessors were not blinded to group allocation. We judged risk of bias to be unclear since the assessment of some measures included a judgement of the outcome assessors not blinded to group allocation (e.g. whether a fixed table at the wheelchair was used as a restrictive measure or not).
Incomplete outcome data (attrition bias)
All outcomes Low risk "Overall, our sample had an attrition rate of 17% (i.e. 22 participants passed away before the follow‐up period was completed and four discontinued for other reasons)."
Attrition rates were comparable between studies and the reasons were reported.
Selective reporting (reporting bias) Unclear risk Not registered; no study protocol available. We had insufficient information to permit a judgement of ‘low risk’ or ‘high risk'.