Webster 2006.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: February 2001‐March 2003 |
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Participants |
Number of participants: 631 eligible; 210 randomised; 206 reported Setting: Brisbane Country: Australia Population: mixed Inclusion criteria: > 18 years of age; able to give written informed consent Condition for hospitalisation: general surgery and medical patients who require IUCs as part of their health care Exclusion criteria: patients with a suprapubic catheter or a long‐term IUC who were pregnant or newly diagnosed with gynaecologic cancer Use of antibiotic prophylaxis: not reported |
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Interventions |
Group A (n = 98): removal of IUC at 6 am Group B (n = 97): removal of IUC at 10 pm Size and type of catheter used (e.g. Foley 16F): not reported Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: IUC removal at 6 am B: IUC removal at 10 pm |
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Outcomes | Time between catheter removal and discharge (h) Duration of catheterisation (h) Time to first void (h) Mean volume of first void Recatheterisation/failed trial of void Post discharge urinary problems: retention; difficulty passing urine; pain when passing urine; loin pain; febrile; incontinent |
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Definition of CAUTI or bacteriuria | Not reported | |
Sponsorship/funding | The Queensland Nursing Council and the Queensland University of Technology funded the study. | |
Ethical approval | The hospital’s human research ethics committee approved the study, and the authors obtained informed consent from all participants | |
Notes | Sample size calculation stated The ward or location in which the catheter was inserted and fluid intake in the previous 24 h were also recorded. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Randomization was performed using a computer‐generated table of random numbers supplied by the hospital’s perinatal research centre.” Comment: adequate randomisation method |
Allocation concealment (selection bias) | Low risk | Quote: “Individuals were allocated to either to 22:00‐hour catheter removal (intervention group), or to 06:00‐hour catheter removal (control group) by telephone call to a scientist who was independent of the recruitment process and blinded to baseline interview.” Comment: adequate concealment method |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: “Neither the clinicians nor the patients were blinded to the intervention.” Comment: blinding of participants and staff is not possible |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: “Ward staff, who were aware of group assignment but who were not part of the research team, recorded outcome data. Data were processed and coded by a researcher who was unconnected with treatment but who was not blind to randomization.” Comment: attempts were made to blind outcome assessment but still prone to detection bias |
Blinding of microbiological outcome (detection bias) | Low risk | No microbiological outcome reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All data reported in full. No exclusions or withdrawals |
Selective reporting (reporting bias) | Low risk | All outcomes reported in full in methods and results sections |
Other bias | Low risk | Appears to be free from other sources of bias |