Chen 2013.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: April‐November 2008 |
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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 |
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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) |
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Outcomes | Total CAUTIs Asymptomatic bacteriuria Symptomatic UTI Catheter‐associated asymptomatic bacteriuria Catheter‐associated symptomatic UTI Duration of catheterisation (mean, SD) Recatheterisation |
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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 |