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

Hess 2008.

Methods
  • Study design: cross‐over RCT

  • Power calculation: yes

  • Intention‐to‐treat analysis: no

Participants Inclusion criteria
  • Setting: spinal cord injury service in Veterans Admin Hospital; single centre

  • Country: USA

  • Number: 57 randomised; 47 analysed

  • Median age: 53 years

  • Sex (M/F): all men


Exclusion criteria
  • Spinal cord injury duration < 12 mo; GFR < 30 mL/min; immunosuppression; current malignancy

Interventions Treatment group
  • Cranberry tablet: 500 mg twice daily


Control group
  • Placebo tablet: rice flour, matched to cranberry tablet

Outcomes
  • Primary outcome: symptomatic UTI

  • Secondary outcome: significant bacteriuria; at least 1 UTI over 6 months; rate of UTI/person‐years

Notes
  • Cross‐over design without data on 1st phase being separate, not analysed

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No method reported
Allocation concealment (selection bias) Low risk Concealed, managed by the pharmacy
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Blinding stated
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Unsure if outcome assessors blind, but all others were and outcome is objectively measured
Incomplete outcome data (attrition bias) 
 All outcomes High risk 10 patients lost to follow‐up and no details provided
Selective reporting (reporting bias) Low risk Appropriate outcome
Other bias Low risk No apparent additional bias
Source of funding: NS