Background
Methods
Design
Participants
Eligibility criteria
Patient recruitment
Interventions
Control group: conventional treatment only
Intervention group: physiotherapy plus conventional treatment
Randomization and blinding
Outcomes
According to the ROME III criteria, a child must have a developmental age of at least 4 years and fulfill two or more of the following criteria, at least two months prior to diagnosisa: | |
1) two or fewer defecations in the toilet per week, | |
2) at least one episode of fecal incontinence per week, | |
3) history of retentive posturing or excessive volitional stool retention at least once a week, | |
4) history of painful or hard bowel movement at least once a week, | |
5) presence of a large fecal mass in the rectum at least once a week, | |
6) history of large diameter stools that may obstruct the toilet at least once a week. |
Measurements
Measurement of the primary outcome
Measurement of secondary outcomes
Sample size
Statistical analyses
Economic evaluation
Process evaluation of adaptations to the original study design
Criteria for participant eligibility
Sample size calculation
Representativeness of the finally selected study population
Participants (N = 134) | Non-participants (N = 90) | |
---|---|---|
Age (mean, SD) | 7.5 ± 3.46 | 8.23 ± 3.80a |
Gender (% girls) | 61.2 | 60.0a |
Referred to study by: | ||
- GP (incident case), (n, %) | 22 (17%) | 22 (24%) |
- Pediatrician (incident case), (n, %) | 6 (4%) | 5 (6%) |
- GP (prevalent case), (n, %) | 106 (79%) | 63 (70%) |
Chronicity of symptoms before randomization b, c | ||
-Yes (n, %) | 67 (65%) | 16 (43%) |
-No (n, %) | 36 (35%) | 21 (57%) |