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. 2018 Sep 7;2018(9):CD005465. doi: 10.1002/14651858.CD005465.pub4

Wolf 2013.

Methods RCT (individually randomised)
Participants Setting: Subacute hospital setting, single geriatric ward, Germany
N = 98
Sample: 65% women
Age (years): 76.1
Baseline Characteristics
Bed‐exit alarm
  • N: 48

  • Age ‐ mean (SD) : NR

  • Female ‐ N (%): NR

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: N


Usual care
  • N: 50

  • Age ‐ mean (SD) : NR

  • Female ‐ N (%): NR

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: N


Inclusion criteria: patients at high risk of falls defined by a score of 3 or more in STRATIFY; requirement for assistance with mobilization during resting time
Exclusion criteria: immobility; participation in another trial
Pretreatment differences: NR
Interventions Intervention Characteristics
  • Bed‐exit alarm. Patients fitted with sensors to upper leg at rest time. Based on Wireless Sensing Triple Axis Reference Design. Sensors worn during rest periods 1 to 3 pm and 8 pm to 6 am.

  • Usual care

Outcomes
  • Number of falls

  • Number of fallers

Duration of the study During admission period, total trial period 13 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Judgement comment: method of sequence generation not described in adequate detail
Allocation concealment (selection bias) Unclear risk Judgement comment: no information provided about allocation methods
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Judgement comment: not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Judgement comment: falls recorded by nurses who were not blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Judgement comment: author correspondence indicated no loss to follow‐up
Selective reporting (reporting bias) Unclear risk Judgement comment: no protocol identified
Method of ascertaining falls Unclear risk Judgement comment: no falls definition provided, standard reporting mechanisms used
Baseline imbalance Unclear risk Judgement comment: inadequate details on baseline characteristics of patients to make a judgement
Other bias Low risk Judgement comment: none detected