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. 2017 Aug 8;2017(8):CD006008. doi: 10.1002/14651858.CD006008.pub4
Methods DESIGN: Randomised controlled cross‐over trial BLINDING PROCEDURES: No SAMPLE CALCULATION: No DURATION: 1 week WITHDRAWALS/DROPOUTS: 2 ITT: Not applicable GEOGRAPHICAL LOCATION: UK SETTING: Two test centres
Participants N = 27 DIAGNOSIS: Not stated. ELIGIBLE: Not stated ENROLLED: 27 COMPLETED: 25 AGE: Adults GENDER: Not stated
Interventions Hydrophilic‐coated catheters, one activated and one not activated (water added by user)
Outcomes User satisfaction and ease of use
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) All outcomes Low risk No blinding, but the review authors judge that the outcome and outcome measurement are not likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes Low risk Participant‐reported outcome, but risk of detection bias considered low as cross‐over trial
Incomplete outcome data (attrition bias) All outcomes Unclear risk Missing outcome data from 2 participants ‐ withdrawals described as catheter‐related reasons, but type of catheter not specified
Source of Funding Unclear risk Coloplast A/S