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. 2012 Oct 17;2012(10):CD001321. doi: 10.1002/14651858.CD001321.pub5

PACS Study 2008.

Methods
  • Study design: 3‐arm parallel RCT

  • Power calculation: no

  • Intention‐to‐treat analysis: appears all were included

Participants
  • Setting: 4 dementia units

  • Country: USA

  • Elderly mean and women > 60 years of age with dementia and a resident of a nursing home or assisted living facility for > 30 days

  • Number: 56 randomised and analysed

Interventions Treatment group 1
  • Cranberry capsule: 1 x 650 mg once daily


Treatment group 2
  • Cranberry capsule: 1 x 650 mg twice daily


Control group
  • No treatment

Outcomes
  • Number of urine cultures collected

  • Number of participants with E.coli isolated from urine culture

  • Number of participants with > 100,000 cfu/mL if any organism

Notes
  • Details from clinical trials register, not from a published paper

  • Designed as a feasibility pilot for a larger study, wanted to determine if collecting urine was feasible

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details on this aspect
Allocation concealment (selection bias) Unclear risk Open label study, could be possible to subvert randomisation
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open label study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open label
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Expected number of urine samples was less than expected.
Losses to follow‐up/withdrawals: 2 lost and 28 did not complete treatment
Selective reporting (reporting bias) Unclear risk Outcomes are about feasibility not efficacy
Other bias Unclear risk Many details missing or poorly detailed
Source of funding: NS