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. 2015 Aug 24;2015(8):CD004464. doi: 10.1002/14651858.CD004464.pub3

Kenefick 2002#.

Methods Randomised crossover trial
 Blinding: participant and investigator
 Follow‐up: the study consisted of two 2‐week intervals with subsensory stimulation either 'on' or 'off'
 Setting: single centre UK
 Withdrawals: none
 Intention‐to‐treat analysis: yes
Participants Enrolled: 2
 Age: both aged 36
 Gender: female (2)
 Duration of symptoms: not stated
 Received permanent implant: 2
 Inclusion criteria: failed maximal conservative treatment; psychologically stable; normal sigmoidoscopy; prolonged whole gut transit time; delayed evacuation
 Exclusion criteria: not stated
Interventions Both participants had a successful 3‐week trial of percutaneous stimulation before one‐stage permanent implantation of a stimulator to the S3 foramen.
A Intervention: stimulator On for two weeks with subsensory stimulation
B Control: stimulator Off
No treatment‐free period between the weeks
Outcomes Bowel frequency (per 2 weeks); time with pain and bloating (%); Wexner constipation score (0 to 30); Symptom analogue score (0 to 100); anal manometry
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Unclear: 'Randomised crossover trial'.
Allocation concealment (selection bias) Unclear risk Unclear: 'Randomised crossover trial'.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessor blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Results were reported for everyone who entered the studies and the participants were analysed in the groups to which they were originally allocated, effectively resulting in an intention‐to‐treat analysis.
Selective reporting (reporting bias) Unclear risk The results of the Short Form 36 quality of life questionnaire were not reported in results table.
Other bias Low risk None identified.