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. |