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. 2021 Jun 29;2021(6):CD004011. doi: 10.1002/14651858.CD004011.pub4

Gross 2007.

Study characteristics
Methods Study design: RCT
Dates study conducted: not reported
Participants Setting: Kentucky
Country: USA
Population: mixed
Age (mean (SD)): 70.3 (11.7)
Inclusion criteria: presence of IUC on admission or inserted during rehabilitation programme; age ≥ 18 years; medical order for catheter removal
Condition for hospitalisation: stroke
Exclusion criteria: not reported
Number of participants: eligible, not reported; 45 randomised; 45 reported
Use of antibiotic prophylaxis: not reported
Interventions Group A (n = 26): IUC removal at 10 pm the day the order for removal was written
Group B (n = 19): IUC removal at 7 am the day after the order form for removal was written
Size and type of catheter used: not reported
Study definition of short‐term catheterisation (days): not reported
Intended duration of catheterisation for each group:
Group A: IUC removal at 10 pm
Group B: IUC removal at 7 am
Outcomes Time to first void
Post‐voided residual urine
Volume of first void
UTI
Definition of CAUTI or bacteriuria The CCD criteria for UTI provided the defining characteristics to determine the presence of infection on admission to rehabilitation
Sponsorship/funding Not reported
Ethical approval “Institutional review board approval was obtained.”
Notes IUCs had been in place an average of 18.2 days (SD = 19.3), a time interval closely corresponding to the length of time since stroke onset (mean 20.5 days, SD 21.3)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “Subjects were randomized to groups by drawing sealed envelopes indicating group designation.”
Comment: unclear as to how randomisation was done
Allocation concealment (selection bias) Low risk Quote: “…by drawing sealed envelopes …”
Comment: adequate method of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Not reported, unlikely to have been blinded as to which participant belonged to which intervention. Not possible
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported
Blinding of microbiological outcome (detection bias) Low risk Urine samples would be sent to a laboratory where the allocation of a participant would not be known
Incomplete outcome data (attrition bias)
All outcomes High risk Recatheterisation data are not presented in the results table 2 (summary of outcomes)
Selective reporting (reporting bias) High risk Recatheterisation is mentioned as an outcome in the methods section but it is not represented in the results section.
Other bias Low risk Appears to be free from other sources of bias