Nyman 2010.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: April 2006‐March 2007 |
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| Participants |
Number of participants: 348 eligible; 113 randomised; 113 reported Country: Sweden Population: mixed Age (mean and SD): A 79 ± 11.0; B 80 ± 11.2 Inclusion criteria: patients with a hip fracture in need of surgery Condition for hospitalisation: hip fracture; < 50 years Exclusion criteria: < 50 years, had a IUC at the time of admission, showed signs of cognitive impairment or had additional severe physical problems at admission. Use of antibiotic prophylaxis: not reported. However, skin disinfectant was used |
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| Interventions |
Group A (n = 55): use of clamping in IUC Group B (n = 58): free drainage of IUC Size and type of catheter used: 14 FR Foley catheter Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: IUC clamped and removed at 6 am on post‐op day 2 B: free‐draining IUC removed at 6 am on post‐op day 2 |
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| Outcomes | Time required to return to normal bladder function (median (quartiles)) Need for recatheterisation (%) Length of hospital stay, days (mean ± SD) |
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| Definition of CAUTI or bacteriuria | Not reported | |
| Sponsorship/funding | This research was supported by grants from the Department of Orthopaedics Orebro University Hospital and Centre for Assessment of Medical Technology, Orebro County Council | |
| Ethical approval | Those who agreed to participate signed informed consent forms before data collection. Ethical approval was obtained from the regional ethical review board of Uppsala, Sweden. | |
| Notes | In the Cochrane Review (Griffiths 2007), two trials reported that clamping reduced the time patients needed to return to normal bladder function. However, this trial could not verify those findings. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “The researcher carried out randomisation using sealed envelopes placed in a random order in two boxes, one for men and one for women” Comment: adequate method of randomisation |
| Allocation concealment (selection bias) | Low risk | Quote: “…through a concealed allocation to the clamped catheter group” Comment: adequate method of allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: “Blinding of group assignment for nurses and patients was not possible in this study.” Comment: blinding was not possible in this study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “The primary outcome in this study, return to normal bladder function, was measured with a bladder scan, which is an objective measure (Bent et al. 1997). The measurements were performed in a similar way by the nurses. However, the measurements were made by different persons, and a disadvantage in this study is that the reliability of the measurements was not confirmed.” Comment: unlikely that outcome measure was affected by blinding |
| Blinding of microbiological outcome (detection bias) | Low risk | No microbiological outcomes reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “Five patients did not receive the treatment they were initially randomised to, four patients removed their indwelling catheter themselves by mistake and three patients were transferred to other wards … Adherence to the randomization was 95%” Comment: reasons for withdrawals and exclusions are valid. |
| Selective reporting (reporting bias) | Low risk | All outcomes in methods were accounted for in the results section. Protocol not available |
| Other bias | Low risk | Appears to be free from other sources of bias |