2.1

Participants and data collection

This multicentric observational study was conducted across 5 French paediatric centres from October 2009 to May 2012. On the basis of medical files in each centre, we included all children and/or their parents who were trained in TAI with the Peristeen® device between October 2009 and June 2011. Inclusion criteria were agreeing to use the TAI system at the end of the training procedure organized by the participating centre. The indication for TAI was insufficient first-line medical, dietary and educational treatments available for FI and/or FC. No exclusion criteria were predefined.

A prospective assessment of the adherence to treatment with TAI was performed between March and May 2012. Nine months separated the 2 interventions (June 2011 to March 2012), which allowed for reduced adherence to the treatment. After patient information and approval, children (or their parents) completed a questionnaire ( Appendices 1 and 2 ), by phone or during a medical consultation, asking if they were still using TAI at home, how they used it, and whether they had experienced any problems or complications. If they were no longer using TAI, they were asked to explain why they had stopped and when.

2.2

Intervention

During educational sessions by expert nurses, the children and/or their families were trained in how to use the TAI system for self-care or care by another person. The training was supervised by the expert nurse with a special focus on the irrigation parameters (including conditions for introducing the catheter when using the toilet, number of pumps required for balloon inflation, and volume of water used for irrigation). Progress and difficulties were reported at subsequent sessions. The expert nurse remained in contact in person, by telephone or by email in case of difficulties.

2.3

Outcome measures

A data sheet was completed for each child included in the study, retrospectively collecting medical details regarding demography, aetiology of colorectal disorders, initial symptoms, treatment of bowel dysfunction before TAI, assessment before initiating TAI, and training and follow-up modalities of TAI. The symptoms were defined as:

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  FI, the involuntary loss of faeces, solid or liquid ;

  
  
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  constipation by 2 of the Rome IV criteria: difficulties in exoneration and < 3 stools per week .

These data were collected in a standard manner in patients’ records, so missing data were exceptional (4 for causal pathology, 1 only for learning modalities).

Adherence to treatment with TAI was prospectively assessed between March and May 2012. Children or their parents completed a questionnaire by phone or during a medical consultation that asked if they were still using TAI at home, how they used it, and whether they had experienced any problems or complications. If children were no longer using TAI, they were asked to explain why they had stopped and when.

2.4

Statistical analysis

Analyses involved using SPSS v18.0 (IBM Inc.). Categorical data are described with number (%). Continuous data are described with mean (SD) and range. Univariate analyses were performed to detect the main differences between the children who stopped and continued TAI. Comparisons involved using Chi ² test or Student t -test. P < 0.05 was considered statistically significant.