Gross 2007.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: not reported |
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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 |
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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 |
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Outcomes | Time to first void Post‐voided residual urine Volume of first void UTI |
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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 |