| Methods |
Design: three group parallel trial
Purpose: examine the effect of the additional treatment of an oral laxative 'Senokot' in patients with faecal soiling already treated with behavioural therapy |
| Participants |
Patients: children with severe and persistent faecal incontinence
Baseline comparability: yes |
| Interventions |
Placebo: tablet without laxative
Untreated: no tablet
Experimental: tablet with laxative 'Senokot'
(Co‐intervention: behavioural therapy) |
| Outcomes |
Number of children soiling more than once weekly |
| Notes |
Tablets delivered in packs marked A and B; selection bias may therefore have occurred, if the code was broken |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'...the psychiatrist and psychologists did not know which tablets actually contained the laxative' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient (parents) reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Unclear risk |
Tablets delivered in packs marked A and B; selection bias may therefore have occurred, if the code was broken |
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
High risk |
N = 26 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
