Allen 2016.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: February 2012‐August 2014 |
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| Participants |
Number of participants: 374 eligible; 374 randomised (217 (58%) men and 157 (42%) women), 247 reported Setting: Minnesota Country: USA Population: mixed Age (median and range): median age 61.5 (21‐87); A 61.1 (31–85); B 61.7 (21–87) Inclusion criteria: patients undergoing a general thoracic surgical procedure, in whom an epidural catheter was placed for analgesia Condition for hospitalisation: general thoracic surgical procedure, in whom an epidural catheter was placed for analgesia Exclusion criteria: patients aged < 18 years, those who died in the hospital within 30 days of the operation, length of stay was < 48 h, epidural catheter was removed before post‐operative day 2, with suprapubic catheter or no bladder, required a urologist or a urologic technician to insert the IUC at the time of the operation, intermittently catheterised pre‐operatively, known UTI pre‐operatively, and who required the IUC to be kept in place because of the need for close monitoring of urinary output Use of antibiotic prophylaxis: not reported |
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| Interventions |
Group A (n = 121): IUC removed within 48 h post‐op Group B (n = 126): IUC removed within 6 h after epidural removal Size and type 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: Group A: IUC removal within 48 h post‐op Group B: IUC removal 6 h after epidural removed |
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| Outcomes | Number of participants requiring recatheterisation Incidence of UTI Length of hospitalisation |
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| Definition of CAUTI or bacteriuria | Not reported | |
| Sponsorship/funding | Not reported | |
| Ethical approval | Not reported | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “A computerized random number generator and double‐blinded envelope system were used to randomize patients 1:1 to removal of the urinary catheter within 48 hours of leaving the operating room or to removal 6 ± 4 hours after the epidural catheter was removed." Comment: computer randomisation used |
| Allocation concealment (selection bias) | Low risk | Quote: “A computerized random number generator and double‐blinded envelope system were used to randomize patients 1:1 to removal of the urinary catheter within 48 hours of leaving the operating room or to removal 6 ± 4 hours after the epidural catheter was removed." Comment: double‐blinded envelope system used |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely this is possible |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Blinding of microbiological outcome (detection bias) | Low risk | Not reported Comment: likely samples were sent to a laboratory and thus unlikely that microbiologist knew which patient was in the study |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No ITT analysis, explanations given for data deemed ineligible for analysis but numbers not reported per randomised group |
| Selective reporting (reporting bias) | Low risk | Outcomes seem to be reported in full |
| Other bias | Low risk | Appears to be free from other sources of bias |