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

Chen 2013.

Study characteristics
Methods Study design: RCT
Dates study conducted: April‐November 2008
Participants Number of participants: 509 eligible; 278 randomised; 278 reported
Setting: Taiwan
Population: mixed
Age (mean (SD): A 77 (12.7); B 78 (10.5)
Inclusion criteria: all adult patients admitted to respiratory ICU
Condition for hospitalisation: multiple. Most of the patients in the study had respiratory failure and were being treated with mechanical ventilation.
Exclusion criteria: had not had IUC; did not stay in respiratory ICU for > 2 days
Use of antibiotic prophylaxis: not used. Antibiotics were only given to symptomatic patients
Interventions A: Intervention group – use of IUC removal reminder protocol (n = 147)
Group 1 (n = 86): IUC removed ≤ 7 days
Group 2 (n = 61): IUC removed > 7 days
B: Control group i.e. no IUC removal reminder policy (n = 131)
Group 1 (n = 48): IUC removed ≤ 7 days
Group 2 (n = 83): IUC removed > 7 days
Size and type of catheter used: not reported
Study definition of short‐term catheterisation (days): not reported
Intended duration of catheterisation for each group:
A: intervention group – use of catheter removal reminder protocol
Group 1 (catheter removed ≤ 7 days)
Group 2 (catheter removed > 7days as clinically indicated)
B: control group i.e. no catheter removal reminder policy
Group 1 (catheter removed ≤ 7 days)
Group 2 (catheter removed > 7days as clinically indicated)
Outcomes Total CAUTIs
Asymptomatic bacteriuria
Symptomatic UTI
Catheter‐associated asymptomatic bacteriuria
Catheter‐associated symptomatic UTI
Duration of catheterisation (mean, SD)
Recatheterisation
Definition of CAUTI or bacteriuria Determination of CAUTI was performed in accordance with criteria of the CDC and the National Healthcare Safety Network, including symptomatic UTI and asymptomatic bacteriuria. A CAUTI is a UTI that occurs in a patient who had an IUC in place within the 48 h before the onset of the UTI.
Sponsorship/funding “This study was supported in part by a research grant from Taipei Veterans General Hospital (Taipei VGH‐V97A‐055)”
Ethical approval The study was approved by the appropriate institutional review board before implementation.
Notes Patients whose IUCs were removed later than planned were excluded from the per‐protocol analysis and were moved to a treatment‐contamination group. Protocol was not followed
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Computer‐generated random numbers were used …”
Comment: adequate randomisation method
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: “These professionals had no knowledge of which group (control or intervention) a patient was assigned to ... most patients had respiratory failure and were being treated with mechanical ventilation.”
Comment: adequate method of blinding. Unlikely participants knew due to being in ICU
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: “The investigator responsible for the daily identification and assessment of all patients with indwelling urinary catheters, however, knew which group each patient was assigned to”
Comment: outcome assessment was not blinded
Blinding of microbiological outcome (detection bias) Low risk Quote: “… all samples were sent to the laboratory…”
Comment: unlikely laboratory staff knew which patients were in the trial
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Unclear. 278 patients were randomised but in table 3 there are 180 in group A and 181 in group B
Selective reporting (reporting bias) Low risk All outcomes are reported in both methods and results sections
Other bias Low risk Appears to be free from other sources of bias