Clinic-based interventions
An RCT conducted in the UK133 (2004) [EL=1+] evaluated the effectiveness of a nurse-led clinic (NLC) compared with a consultant-led paediatric gastroenterology clinic (PGC) in the management of chronic idiopathic constipation. The study included 102 children aged 1 to 15 years presenting to the paediatric gastroenterology service at the John Radcliffe Hospital, Oxford, UK with constipation (55 males, median age at study entry 4.6 years (NLC) and 4.8 years (PGC), age range 13 months to 14.7 years). Children were randomised to be followed up at an NLC or a PGC. The nurse-led clinic was designed to be a follow-up clinic for children who had undergone a full and detailed medical assessment in the PGC leading to a diagnosis of ‘idiopathic functional constipation’. Where it was clinically appropriate, an abdominal radiograph was obtained at the time of initial assessment, both as a diagnostic tool and as a semi-quantitative marker of the severity of constipation. A standardised treatment algorithm (constructed for the study, similar to a number of published guidelines) provided the basis for management decisions in all consultations in both clinics.
Initial phases involved child and parent education about diet (fibre and fluid), exercise, toilet training and the actions of the laxatives prescribed. Laxative therapy comprised a combination of stool softeners (for example, lactulose, docusate sodium) and stimulants. Stimulants of different potencies (senna, bisacodyl, sodium picosulfate) were prescribed according to the clinical response as indicated by the children's bowel diaries. If there was an inadequate clinical response to this initial phase, the patient moved on to an advanced treatment regimen which might include enemas, intestinal lavage, manual removal of faeces under general anaesthesia or psychological referral as appropriate in each case. Bowel diaries, which report the frequency, size and consistency of stools, presence or absence of soiling, and a record of daily laxative medication, were used in both clinics to monitor progress and response to treatment. Dedicated case report forms were used for each study participant which, together with detailed clinical history (including a detailed dietetic history) and clinical findings on initial assessment, documented details of bowel habits and drug therapy at all subsequent outpatient visits. Any other contact with the families, such as on the telephone or as part of a home visit, was documented using inter-visit contact forms.
A child was defined as having been ‘cured’ of their constipation when, for a period of at least 1 month, they had been opening their bowels and producing a normal formed stool without difficulty at least 3 times per week, without any laxative therapy. ‘Time to cure’ relates to all those children confirmed cured either at their last visit or subsequently confirmed over the telephone. Children who were close to achieving the definition of ‘cured’ at their last visit but who were still being weaned off medication were not required to attend for a further follow-up appointment but received their follow-up via the telephone. ‘Time to cure at last visit’ relates to only those children confirmed cured at their last visit (a subset of the previous outcome). ‘Premature study termination’ comprised those patients who were either lost to follow-up or withdrawn for whatever reason.
Fifty-nine children were confirmed to be cured at last visit or later confirmed by telephone; of these, 49 were confirmed to be cured at the last visit. Of those children cured at their last clinic visit or confirmed by subsequent telephone follow-up, 34 of 52 (65.4%) were cured in the NLC and 25 of 50 (50.0%) in the PGC. The median time to cure was 18.0 months in the NLC (95% CI 8.5 to 27.5) and 23.2 months in the PGC (95% CI 17.3 to 29.2). The probability of cure was estimated as 33% higher in the NLC compared to the PGC (hazard ratio 1.33, one sided 95% CI 0.86 to ∞; P = 0.3). Attending the NLC hastened time to cure by a factor of 0.816 (one sided 95% CI 0 to 1.032): compared to the PGC, the NLC reduced time to cure by an estimated 18.4%. Children who attended the NLC were equally as likely to be cured as those attending the PGC, but their cure was more likely to occur earlier. More children were cured in the NLC (27 of 52 versus 22 of 50 in PGC) and median time to cure was reduced (22.1 versus 25.1 months in PGC).
Five children in the NLC (9.6%) and 14 in the PGC (28.0%) were lost to follow-up or withdrawn. The risk of premature study termination was significantly reduced by an estimated 66% in the NLC compared to the PGC (hazard ratio 0.33, one sided 95% CI 0 to 0.79; P = 0.036). The median number of visits in each clinic was 6.0. The median number of inter-visit contacts to the NLC was 6.0 (range 2 to 16) compared to median 0.0 inter-visit contacts to the PGC (range 0.0 to 29). The number of patients requiring additional medication or in-patient procedures during the scheduled treatment period was not significantly different between both groups.
Ten children (five NLC, five PGC) completed the study as per the protocol but were not cured (treatment failures): of these ten, eight children were formally referred for psychological and/or psychiatric management, nine had documented serious behavioural problems and three were also referred for surgical assessment and management. A total of 15 out of 102 children were still undergoing follow-up, as they were not cured. In this group, seven children were followed up in the PGC and eight in the NLC. Seven of 15 children had documented psychosocial problems associated with poor compliance in attending clinic appointments. Baseline demographic and clinical presentation characteristics as well as previous laxative usage were well balanced across clinics. Intention to treat analysis was conducted for all outcomes. Survival analysis was conducted for the primary time-to-event outcomes
A survey RCT conducted in the UK1 (2006) [EL=1+] assessed parents' satisfaction with an NLC for children with intractable, functional constipation compared with a consultant-led PGC. This study is a follow-up evaluation of the RCT reported above. The study included 102 children aged 1 to 15 years presenting to the paediatric gastroenterology service at the John Radcliffe Hospital, Oxford, UK with constipation (55 males, median age at study entry 4.6 (NLC) and 4.8 years (PGC), age range 13 months to 14.7 years). Parents' satisfaction was measured after 12 months' follow-up or before this if the child had been ‘cured’. Satisfaction with care was defined as ‘the degree to which parents perceive the needs of their children are met’. Parent satisfaction was measured using a validated instrument based on the Leeds satisfaction questionnaire (LSQ). Five-point Likert scales were used for responses ranging from ‘strongly agree’ to ‘strongly disagree’; stability of the instrument was tested using the test-retest method. An attempt was made to record all ‘inter-visit’ contacts (by telephone or day ward attendances) made by parents outside their scheduled outpatient's appointment.
A total of 90 questionnaires were returned from 107 families canvassed (84%); 40 out of 51 (78%) from the PGC and 50 out of 56 (89%) from the NLC. The NLC scored significantly higher in most of the outcomes measured (all values are median):
provision of information (NLC: 8.7 versus PGC: 7.5; P < 0.001),
empathy with patient (NLC: 9.0 versus PGC: 7.3; P < 0.001),
technical quality and competence scores (NLC: 9.1 versus PGC: 8.0; P < 0.001),
attitude towards the patient scores (NLC: 8.7 versus PGC: 7.3; P < 0.001),
access to and continuity with the caregiver scores (NLC: 8.2 versus PGC: 6.7; P < 0.001)
overall satisfaction scores (NLC: 8.7 versus PGC: 7.3; P < 0.001).
There were no significant differences between the NLC and PGC regarding the number of inter-visit contacts. Intention to treat analysis was performed for all outcomes. It should be noted that an extra five children were included in this follow-up, but there is no explanation for this in the paper.
A prospective case series conducted in Canada134 (1997) [EL=3] presented the experience of the first 16 months of a multidisciplinary clinic for the treatment of functional constipation. The study included 114 children aged up to 19 years referred to the clinic with constipation after a 3-month unsuccessful course of treatment (51.4% boys, mean age 5.4 ± 3.8 years, range 4 months to 19 years). The bowel management clinic (BMC) was staffed by a physician (rotating between two paediatricians, a paediatric gastroenterologist and a paediatric general surgeon), a nurse practitioner, a dietician, an enterostomal therapist/nurse educator and a psychosocial nurse specialist. All new patients were always assessed by a clinic nurse and physician to identify potential organic causes of constipation and to establish components of individualised management. Patients were offered further referral to other BMC staff as needed. Investigations were only performed if there was suspicion of organic cause of constipation or lack of improvement after adequate intervention (abdominal radiograph with lumbosacral spine, barium enema, anorectal manometry and rectal mucosa biopsy).
The only compulsory treatment modality was patient education. Enemas were only used in the initial treatment of faecal impaction, to provide social continence for children with persistent encopresis and avoid undue rectal distension until laxatives could start taking effect. The choice of enemas was phosphate and tap water or saline. High colonic saline irrigations were used in severe cases; suppositories were not routinely employed. The choice of laxative was based on compliance and nature of symptoms. Most patients were treated with senna, docusate sodium and mineral oil. Multiple laxatives were avoided. Patients started on recommended dosages, and then increased by 50% every 4 to 5 days until symptomatic improvement was noted. Individualised dosage was then maintained for a minimum of 3 to 6 months, during which dietary and psychosocial issues were dealt with. Patients were then slowly weaned off medications.
Follow-up was arranged by each healthcare professional as needed. Visits were used to monitor progress and continue the education process. Patients who showed no progress were reassessed by a physician and could become candidates for diagnostic testing. Patients were discharged when asymptomatic and off medications. Patients were then referred back to the referring physician, with information for maintaining healthy bowel routine. Outcome measures were stool frequency per month, stool consistency, occurrence and frequency of symptoms (soiling, rectal pain, rectal bleeding) and satisfaction with care. Sample size varies in each category of symptoms because of incomplete observations and stool frequencies were only included for non-soiling patients. Also, a Measure of Processes of Care (MPOC) questionnaire was administered at the 4-month point. MPOC is a self report measure of the parents' perceptions of the extent to which five behaviours of healthcare professionals occur (respectful and supportive care, enabling and partnership, providing general information, providing specific information, and coordinated and comprehensive care). The scores from the study group were compared with those from a normative group of 653 patients (no further details provided).
The total number of visits was 257 with an average of six patients per clinic. Sixty-two patients were seen more than once with a mean of 3.1 visits per patient and a mean time span between the first and the last visit to clinic of 4.5 months. The average stool frequency per month (n=26) increased significantly from the first to the last visit (11.73 versus 29.77; P = 0.00026). Stool frequencies were only included for non-soiling patients. Stool consistency (n=55) () improved from the first to the last visit, although it is unclear whether the figures refer to the numbers or percentage of children (liquid: 0 versus 1, soft: 4 versus 13, formed: 16 versus 13 and hard: 10 versus 3; P = 0.00004). The proportion of children who experienced soiling (n=42) did not change significantly from the first to the last visit. Significantly fewer children experienced rectal pain and rectal bleeding at the last visit compared to the first visit (rectal pain (n=51): first visit: 53% versus last visit: 22%; P = 0.0003 and rectal bleeding (n=54): first visit: 26% versus last visit: 4%; P = 0.00035). The frequency of soiling per month (n=26) decreased significantly from the first to the last visit (30.7 versus 12.8; P = 0.015). There were no significant differences regarding the frequency of rectal pain per month and the frequency of rectal bleeding per month from the first to the last visit.
Satisfaction with care scores was normal or higher than those in the normative group of children for: respectful and supportive care, enabling and partnership, and coordinated and comprehensive care. Scores were lower than the normative group for providing general information and providing specific information. Results were only reported in a graph from which it is difficult to extract estimates. Thirteen children appeared to be lost to follow-up (no return to clinic in over 6 months) and 11 were discharged. Among those discharged the mean number of clinic visits was 3.5.
Internet-based interventions
A small multicentre RCT conducted in the USA122 (2003) [EL=1+] aimed to examine the utility and effectiveness of an internet-based version of enhanced toilet training. The study included 24 children aged 6 to 12 years, soiling at least once a week, who had no medical diagnosis other than constipation that could explain their faecal incontinence (19 boys, mean age 8.46 years (SD 1.81). Children were randomised to receive the web intervention (n=12, 10 boys) or no intervention (n=12, 9 boys). The intervention was a web-based program for the treatment of paediatric encopresis (U-CAN-POOP-TOO). Exposure to the program lasted for 3 weeks after which an assessment was conducted.
The number of faecal accidents per week decreased significantly more in the web group compared to the group with no web intervention (no-web) (mean 0.50, SD 0.85 versus 8.27, SD 13.83; P = 0.018). The number of bowel movements passed on the toilet per week increased significantly more in the web group compared to the no-web group (152% change from pre- to post-assessment versus -16%; P = 0.001). Using the bathroom without prompts also increased significantly more in the web group compared to the no-web group (109% change from pre- to post-assessment versus -37%; P = 0.021). Using the bathroom with prompts was not significantly different between the two groups.
Among the most useful aspects of the programme that parents cited were: the step by step program to get the child regulated, understanding why his or her body does what it needs to do every day and what happens when he or she doesn't have a bowel movement, and health consequences. Amongst the least useful aspects of the programme that parents cited were: difficulty with connections, modules regarding fear of toilet and ‘monsters’, art work of the body did not print out, PEG 3350 without electrolytes should have been included (as a choice of laxative) and nutrition portion was too limited. Most parents found the material understandable (mean 5.00, SD 0.00, n=20), easy to use (mean 4.62, SD 0.74, n=21), believed their child liked the program (mean 4.05, SD 1.28, n=21), believed their child found it understandable (mean 4.32, SD 0.89, n=19), believed their child found it easy to use (mean 4.47, SD 0.77, n=19). There were no significant differences in baseline characteristics between the two groups (age, gender, race, stage of bowel movement training, length of current laxative regimen or any of the outcomes measured). No dropouts or lost to follow-up were reported, but it should be noted that the numbers involved were small.
An RCT/survey mixed methods study conducted in the USA135 (2005) [EL=1+, RCT component] [EL=3, survey component] determined if families of children suffering from chronic constipation and/or encopresis will visit an educational website that is specifically prescribed by their physician and whether an email reminder increases the likelihood that they will visit the website. In addition, barriers to accessing the prescribed website were identified. The study included families with a child who was being seen for the first time in the paediatric gastroenterology clinic at the University of Virginia with a chief complaint of chronic constipation and/or encopresis. There were 83 families and children (children's mean age 7 years 10 months, median age 94 ± 38 months, age range 25 months to 14.5 years). The website was an abbreviated version of a larger web-based program for the treatment of paediatric encopresis (U-CAN-POOP-TOO).
At the conclusion of the patient's clinic visit, one of the two attending gastroenterologists provided a form with the website address and a log-in identification number. The handout, signed by the physician, stated: ‘It is important to learn as much as you can about bowel problems and how to manage them. As part of your child's care, I want you to go to this website and review the relevant material. This should be beneficial to your child's treatment.’ Families were assigned randomly into a ‘prompt’ group (n=43) or ‘no-prompt’ group (n= 40). Two business days after the clinic visit, an email containing the website address and a reminder to visit the website was sent to those in the ‘prompt’ group. Approximately 1 week after the clinic visit, the study coordinator attempted to contact the primary caretaker of each patient by telephone or email to ask about their experience accessing the website. Families who did not access the website were encouraged to identify barriers that they may have experienced in accessing the prescribed website.
Fifty-four (65%) families visited the prescribed website within 1 week of their clinic visit. Families who received the email remainder were significantly more likely to visit the website than families who did not receive the email remainder (77% versus 53%). Eighteen interviewed subjects did not go to the website. The main reasons for not doing so were reported as: just forgot (61%), didn't have much time (61%) and lost flyer (33%). No parent reported that their child did not cooperate, that they did not know how to use internet or that the family thought the program was a bad idea. No significant differences were found in identified obstacles between the families who received the email reminder and those who did not. There were no significant differences between the two groups on type and speed of internet connection, the number of times they reported checking their email, or frequency of using the internet. There were no significant differences in the ages of the children between the two groups.
A single sample crossover multicentre RCT conducted in the USA136 (2006) [EL=1+] determined the usefulness and user preference for audio (use of sound), graphics (use of images) and interactivity (triggering of events by the user causing various actions, such as clickable buttons) in a paediatric internet-based health intervention specifically designed for patients with encopresis. The study included 49 children aged 5 to 12 years who were being seen for encopresis at two paediatric gastroenterology clinics (32 boys, mean age 7.98 years, SD=1.88). Two modules of the original U-CAN-POOP-TOO intervention were revised: ‘Giving and Getting Enemas’ reviewed techniques for administering enemas and ‘How to Strain’ reviewed proper defecation, dynamics, including proper positioning, straining and muscle control/strength-building exercises. All children received one modified module including audio, graphics and interactivity and then the other module without audio, graphics or interactivity. Design was significantly improved compared with the original intervention, with special emphasis given to graphical, animation and interactive elements.
For each of the three studies conducted, the two modules were modified to either include the three constructs of interest (audio, graphics and interactivity) or not. For the study examining audio both modules were created with and without sound. For the study examining graphics both modules were created with graphics and completely text based, and for the study examining interactivity both modules were created with interaction (use the mouse to click on various aspects of the screen and to navigate) and as a movie (where no interaction was necessary and the participant could just watch the module play from beginning to end). Each module with or without each component was presented once. Participants were assessed immediately after each module was presented. Outcomes measured were motivation and readiness to change. Parents were asked to complete the motivation and readiness to change items from their child's perspective.
Children's motivation significantly improved when the computer audio was used (pre: 6.00 versus post: 5.13; P ≤ 0.004) but not when someone in the room read the content aloud. Parents believed that their children's motivation significantly improved when someone in the room read the content aloud (pre: 8.75 versus post: 7.13; P ≤ 0.02) but not when the computer audio was used. Children's motivation was not affected by either the presence or the absence of graphics but parents believed the presence of graphics improved their children's motivation (pre: 7.13 versus post: 6.06; P ≤ 0.03). Children's motivation significantly improved both with interactive modules (pre: 6.00 versus post: 4.71; P ≤ 0.03) and non-interactive modules (pre: 5.18 versus post: 4.41; P = 0.02) but parents did not believe that was the case for either situation. Readiness to change did not improve for children when the computer audio was used and parents also believed that. Readiness to change did not improve for children when someone in the room read the content aloud but parents believed it did improve (pre: 2.25 versus post: 2.75; P ≤ 0.04). Readiness to change did not improve for children when there were no graphics and parents also believed that. Readiness to change did not improve for children when there were graphics but parents believed it did improve (pre: 2.44 versus post: 2.88; P = 0.01). Children did not improve their readiness to change with either system (interactive modules or non-interactive modules) and parents also believed that.
A prospective case series conducted in the USA137 (2008) [EL=3] examined the utility and impact of the same internet intervention for childhood encopresis as part of standard medical care in a ‘real world’ setting. The study included 22 children with a documented diagnosis of encopresis (as noted in their medical records) and their families, seen at the Paediatric Gastroenterology Clinic at the University of Virginia Children's Hospital (13 males, mean age 8.10 years [SD 2.3 years], range 5.1 years to 12.11 years). All children had been given access to the paediatric encopresis internet intervention as part of their treatment. During 2 weeks all children received an internet-based intervention for childhood encopresis: U-CAN-POOP-TOO. Children were assessed 2 weeks before they were enrolled in the program and 2 weeks after being exposed to the intervention.
The average number of faecal accidents over a 2-week period decreased significantly when comparing the initial period with the follow-up period (13.86, SD 10.40, median 13.00 versus 2.14, SD 2.21, median 1.00; P < 0.001). There were no significant differences between the number of bowel movements (BM) passed in the toilet over a 2-week period or average amount of perianal pain experienced during defecation over a 2-week period when comparing the initial period with the follow-up period. Most parents liked the program (mean 4.62, SD 0.50, n=21), found it understandable (mean 5.00, SD 0.00, n=20), found it easy to use (mean 4.62, SD 0.74, n=21), believed their child liked the program (mean 4.05, SD 1.28, n=21), believed their child found it understandable (mean 4.32, SD 0.89, n=19) and believed their child found it easy to use it (mean 4.47, SD 0.77, n=19).
The most helpful components of the program cited by the parents were: the tutorials about anatomy and pathophysiology, that the program was geared toward the child and that it was comprehensive and non-judgemental. No clear themes emerged regarding the least helpful components of the program: On average, 19 out of 25 items (76%) were rated by the parents as at least ‘somewhat helpful’ and no item described as ‘not at all helpful’. On the 1- to 5-point scale, average responses ranged from a low of 2.33 (the program helped reduce the number of times parents had to remind their child to use the bathroom) to a high of 4.2 (the program helped the child feel more comfortable using the toilet at home). Sixteen out of 22 patients examined stopped using the program for some reason other than that their problem was ‘resolved’. The most cited obstacles to using the program were ‘I just forgot [to go to the website]’ (mean 2.00, SD 0.89) and ‘I didn't have time in my schedule’ (mean 2.06, SD 0.85).
An online survey conducted in the USA138 (2001) [EL=4] described the feedback received regarding a web-based tutorial about chronic childhood constipation and encopresis during 28 months between January 1998 and April 2000. Participants included 1142 children and parents who accessed a tutorial about childhood constipation and encopresis, developed and installed on the web pages of the Children's Medical Centre at the University of Virginia, who also completed an online feedback form. No internal or external announcement was made to communicate the availability of the tutorial, but access to the website was not limited in any way.
The multimedia tutorial was directed primarily at parents and older children. It included information about differential diagnosis, aetiology, treatment and potential side effects, method of follow-up including regular monitoring, natural history and prognosis and a list of references. The one-page feedback form comprised six multiple-choice questions and one open-ended comment field.
Only 887 participants (78%) answered the questions categorising the reader: 789 (89%) were parents and guardians of a child with constipation or encopresis, 44 (5%) were grandparents or other family members, 30 (3%) were teachers, 9 (1%) were physicians and 35 (4%) were other healthcare providers. The tutorial received 157,326 successful page requests from 38,012 distinct hosts.
Of the parents, 812 (92%) said the information presented in the tutorial was ‘very clear’ and easy to understand whereas 71 (8%) said it was ‘pretty clear’ (883 parents answered this question). Nobody chose the ‘not very clear’ or ‘not clear at all’ responses. A total of 509 parents (73%) said the tutorial completely helped them to understand why children develop constipation and/or encopresis while 174 (25%) answered that this had ‘somewhat’ been the case and 13 parents (2%) answered ‘a little’ (696 parents answered this question). No parents chose the ‘not at all’ option. A total of 408 parents (59%) said that after completing the tutorial, they thought they were ‘much’ better able to take care of a child suffering from constipation and/or encopresis; 226 parents (32%) responded ‘somewhat’, 42 (6%) ‘a little’ and 20 (3%) ‘not at all’ (696 parents answered this question). For the question on whether they thought this type of tutorial was a good way to teach people about health problems, 691 answered of whom 599 (87%) thought it was very good, 89 (13%) pretty good and 3 (0.4%) thought it was not good at all. No participant thought the tutorial was ‘not very good’.
There were questions or comments or suggestions as to how to improve the tutorial from 845 parents: 443 (52%) showed an appreciation for making the information available, 167 (20%) had questions about a particular child's symptoms or treatment, 96 (11%) had a general question not specific to any particular child, 46 (5%) made a referral request, 34 (4%) made a request for dietary recommendations, 21 (2%) made a request for additional online information, such as an online forum or a frequently asked questions (FAQ) site and 38 (4%) made specific recommendations about how to improve the tutorial.
