ORIGINAL ARTICLE: GASTROENTEROLOGY

Follow-up in Childhood Functional Constipation:

A Randomized, Controlled Clinical Trial


Line Modin,
Anne-Mette Walsted, yCharlotte S. Rittig,
Anne V. Hansen, and
Marianne S. Jakobsen

ABSTRACT

Objectives: Guidelines recommend close follow-up during the treatment of

childhood functional constipation. Only sparse evidence exists on how
follow-up is best implemented. Our aim was to evaluate whether follow-
up by phone or self-management through Web-based information improved
treatment outcomes.
Methods: In this randomized controlled trial, conducted in secondary care,
235 children, ages 2 to 16 years, who fulfilled the Rome III criteria of
childhood constipation, were assigned to 1 of the 3 follow-up regimens:
control group (no scheduled contact), phone group (2 scheduled phone
contacts), and Web group (access to Web-based information). Primary
outcome: number of successfully treated children after 3, 6, and 12 months.
Secondary outcomes: phone contacts, relapse, fecal incontinence, and
laxative use.
Results: After 3 and 6 months, significantly more children in the Web group
(79.7%/75.9%) were successfully treated compared with the control and
phone groups (59.7%/63.6% and 63.3%/64.6%) (P 0.007/P 0.03).
No difference was found after 12 months (control, 72.7%; phone, 68.4%;
Web group, 78.5%; P 0.40). Extra phone consultations were significantly
more frequent in the Web group (44.3%) compared with the control group
(28.6%) (P 0.04). Before 3 months, 45.5% of phone consultations were
completed in the Web group versus 28.8% and 25.8% in the control and
phone groups (P 0.05/P 0.02). Relapses, fecal incontinence, and
laxative use were not different between interventions.
Conclusions: Improved self-management behavior caused by access to self-
motivated Web-based information induced faster short-term recovery during
the treatment of functional constipation. Patient empowerment rather than
health carepromoted follow-up may be a step toward more effective
treatment for childhood constipation.
Key Words: childhood, constipation, follow-up, information, treatment
(JPGN 2016;62: 594599)
Received June 1, 2015; accepted August 31, 2015.
From the
Department of Pediatrics, Hospital Lillebaelt, Kolding, and the
yDepartment of Pediatrics, Aaarhus University Hospital, Aarhus,
Denmark.
Address correspondence and reprint requests to Line Modin, Department
of Pediatrics, Hospital Lillebaelt, DK-6000 Kolding, Denmark
(e-mail: line.modin@rsyd.dk).
clinicaltrials.gov registration number: NCT01582659.
All phases of this study were funded by the University of Southern Denmark,
Region of Southern Denmark, Department of Pediatrics Kolding, Region
of Southern Denmark, Jubilee Foundation of 12.08.1973, A.P. Moeller
and Wife Chastine Mc-Kinney Moellers Foundation, and Danish
Medical Association Research Foundation.
The authors report no conflicts of interest.
Copyright # 2016 by European Society for Pediatric Gastroenterology,
Hepatology, and Nutrition and North American Society for Pediatric
Gastroenterology, Hepatology, and Nutrition
DOI: 10.1097/MPG.0000000000000974
What Is Known
 Clinical guidelines recommend follow-up during the
treatment of functional constipation to secure adher-
ence and to treat relapses.
 Currently, there is sparse evidence available on how
follow-up is best executed to secure treatment success.
What Is New
 This is the first randomized controlled study evaluat-
ing the effect on treatment outcomes of 3 follow-
up regimens in childhood functional constipation.
 Improved self-management behavior caused by
access to self-motivated Web-based information
induced faster short-term recovery during the treat-
ment of functional constipation.
 Patient empowerment rather than health care
promoted follow-up may be a step toward more
effective treatment for childhood constipation.
F unctional constipation (FC) is a common condition in child-
hood, with an estimated prevalence of 0.7% to 29% (1). The
diagnosis and treatment of FC can be difficult tasks, and children are
often referred to specialist services causing treatment to become
expensive and time-consuming (2,3). The recovery rate is 50% to
60% after 1 year of treatment, with 50% of the children having
relapse within 5 years (46). Current guidelines recommend a 4-step
treatment algorithm in which follow-up is thought to secure adher-
ence and prevent relapse (7). There is no evidence, however, to
whether this is an effective strategy or whether more or less access to
follow-up could be equally or better in terms of treatment outcome.
The present evidence on follow-up is mainly focused on nurse-led
clinics (810). Burnett et al (9) showed that children studied in nurse-
led clinics recovered faster, tended to establish communication more
frequently by using intervisit contacts, and their parent satisfaction
was higher compared with children followed up by pediatric gastro-
enterologists (8,9). In a review by Drotar (11) concerning the
association of health outcomes and treatment adherence, it was shown
that communication and adherence promotion had a positive effect on
clinical outcomes in the care of chronic childhood illnesses such as
asthma. No such studies have been conducted in children with FC. A
recently published guideline did not provide specific recommen-
dations on how to schedule follow-up (12). Therefore, we designed 3
different follow-up regimens where primary outcome was to evaluate
how treatment was affected by either health carepromoted phone
contacts, active self-management through Web-based information, or
no preplanned follow-up contacts. Secondary outcome was to evalu-
ate extra contacts, relapse, fecal incontinence, and use of laxatives.

594 JPGN  Volume 62, Number 4, April 2016

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 JPGN  Volume 62, Number 4, April 2016
METHODS
Patients
The study population consisted of children, ages 2 to
16 years, referred from general practitioners to the pediatric
outpatient clinic at Hospital Lillebaelt, Kolding, between June
2012 and September 2013. To be included, children had to fulfil
2 Rome III criteria for FC for 2 months: defecation frequency
<3 times per week, 1 episode of fecal incontinence per week,
retentive posturing, painful bowel movements, large fecal mass
in the rectum, and large diameter stools. Exclusion criteria
were organic causes of constipation, including Hirschsprung
disease, spinal and anal congenital abnormalities, food allergy,
history of gastrointestinal surgery, inflammatory bowel disease,
or medication known to affect bowel function other than laxa-
tives. Test for celiac disease were made in children persistently
complaining of abdominal pain in spite of successful treatment of
constipation.
Randomization
Personnel outside the study group generated the 3 compari-
son groups using simple randomization, with an equal allocation
ratio, by referring to a table of random numbers stored away from
the allocation site. Patients were allocated by pulling a random
envelope with 1 of the 3 follow-up groups. All envelopes contained
a folded A5 paper and were indistinguishable from another. It was
not possible to use blinding.
Intervention
The study was a parallel, single-center, randomized con-
trolled trial. At inclusion, a detailed medical history and clinical
examination were performed, including digital rectal examination.
All of the 3 intervention groups were treated according to the first 3
steps in the treatment algorithm comprising information, disim-
paction, and maintenance treatment. The information was provided
standardized to all included patients by 1 of the authors (L.M.) and
included facts about FC pathophysiology, instructions for poly-
ethylene glycol 3350 (PEG) disimpaction (1.5 g  kg1  day1),
PEG maintenance treatment, and the use of the Bristol stool chart.
After inclusion, all the children were randomly allocated to 1 of the
3 follow-up regimens: control group (no scheduled contacts),
phone group (2 scheduled phone contacts after 1 and 4 weeks),
and Web group (self-administered access to Web site). The Web
group was provided a password to a Web site containing infor-
mation about childhood FC (pathophysiology, treatment prin-
ciples, Bristol stool scale, PEG administration, toilet training,
and common treatment pitfalls and solutions). Both the phone
and Web groups were provided information on constipation and
advice regarding adjustment of PEG treatment either at the pre-
scheduled phone contacts or through the Web site. All groups had
the possibility to receive extra phone consultations during the
entire study if they felt the need for additional guidance. All the
clinical contacts were recorded.
Data Collection
Primary outcome measure was the number of successfully
treated children after 3, 6, and 12 months. Being successfully
treated was defined as the presence of <2 Rome III criteria with
or without the use of laxatives. Rectal impaction at 3, 6, and 12
months was evaluated by transabdominal ultrasound. A rectal
diameter >3 cm was regarded as a sign of impaction (13,14).
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Follow-up in Childhood Functional Constipation
Secondary outcome measures were extra contacts, relapse, fecal
incontinence, and use of laxatives. Relapse was defined as having
2 Rome III criteria lasting >14 days. All the children were
scheduled for a visit at 3, 6, and 12 months after inclusion, preceded
by a 2-week stool diary. If the family wished to discontinue
participation, clinical data were obtained by phone. Inclusion
was carried out by L.M., whereas 3-, 6-, and 12-month visits were
carried out by L.M. or a trained research nurse. Informed consent
was obtained from parents before inclusion. No changes in protocol
were made during the study course. The study was approved by
the Danish Data Protection Agency and the Medical Ethical Com-
mittee (S-20120016), and registered in the clinical trials database
(NCT01582659).
Sample Size
The required sample size was based on a projected treatment
success in the control group of 60%. The smallest effect of clinical
interest was an absolute increase in treatment success of 35%. To
achieve this difference with a power in excess of 80% and a critical
level of significance of 0.05, 75 patients were needed in each group.
Statistical Analysis
Analyses were performed using STATA 13 (StataCorp LP,
TX). Intention-to-treat analyses were used to compare differences
between the intervention groups. Dropouts were defined as children
who missed data collection visits. Statistical imputation was used to
handle missing data by last-observation-carried-forward analysis
(15). To estimate the effect of dropouts, sensitivity analysis for
extreme cases was performed by replacing missing data with
negative outcomes. By this method, the largest possible negative
influence that missing data could have on outcomes was described.
Clinical characteristics were analyzed in a descriptive way. Logistic
regression with indicator variable was used for binary outcome
variables for group comparisons. For pairwise comparison, x2 test
was used for binary outcome variables, and Fisher exact test was
used for small samples. The unpaired t test was used for continuous
numerical outcome variables. Wilcoxon rank-sum test was used for
data not distributed normally. Statistical significance was defined as
P < 0.05.
RESULTS
Patients
Overall, 235 children were assigned for randomization
(Fig. 1). The randomization secured similar baseline characteristics
in the treatment groups (Table 1). During the study, 16.9% (13/77)
in the control group, 8.9% (7/79) in the phone group, and 11.4%
(9/79) of the children in the Web group dropped out. Among the
29 children who dropped out, 61.5% (8/13), 57.1% (4/7), and 88.9%
(8/9) in the control, phone, and Web groups, respectively, were
successfully treated at their last visit. Phone interview, instead of
face-to-face consultations, was carried out in 14.2% (11/77), 17.7%
(14/79), and 13.9% (11/79) in the control, phone, and Web groups,
respectively. In the phone group, 82% (65/79) completed both
scheduled phone consultations, 15% (12/79) completed 1 phone
consultation, and 3% (2/79) did not complete any phone consul-
tations. When looking at the Web group, only 54% (43/79) had
logged into the Web site at some point during the study. Of those
43 children who used the Web site, the median number of logins
after 12 months was 1 (range 13) in the 32 successfully treated
children and 2 (range 13) in the 11 persistently constipated
children (P 0.19).
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 Modin et al JPGN  Volume 62, Number 4, April 2016

Number assessed (N = 292)

Excluded (n = 53)
41 Not meeting inclusion criteria
12 Declined participation

Randomized (n = 239)

Excluded from ITT (n = 4)

2 Celiac disease
1 Surgery because of anteriorly displaced anus
1 Scleroderma

Included (n = 235)

Control group (n = 77) Phone group (n = 79) Web group (n = 79)

Dropouts*: Dropouts*: Dropouts*:

3 months: 1 dropout 3 months: 0 dropouts 3 months: 1 dropout

1 Loss of contact (constipated) 1 Loss of contact (constipated)

6 months: 4 dropouts 6 months: 1 dropout 6 months: 3 dropouts

1 Moved (constipated) 1 Free of complaints (successfully 3 Free of complaints (successfully
2 No treatment effect (constipated) treated) treated)
1 Loss of contact (successfully treated)

12 months: 8 dropouts 12 months: 6 dropouts 12 months: 5 dropouts

4 Free of complaints (successfully 6 Loss of contact (3 successfully 2 Free of complaints (successfully
treated) treated, 3 constipated) treated)
4 Loss of contact (3 successfully 1 Loss of contact (successfully treated)
treated, 1 constipated) 2 Moved (successfully treated)

77 were analyzed 79 were analyzed 79 were analyzed

FIGURE 1. Patient flow chart. ITT intent-to-treat population. Last known status is stated in parentheses.

TABLE 1. Patient baseline characteristics by intervention group

Demographics Control group (n 77) Phone group (n 79) Web group (n 79) n

Boys, n (%) 41 (53.2) 40 (50.6) 42 (53.2) 235

Age, y, median (range) 5.8 (214.3) 6.3 (2.112.8) 6.3 (2.315.8) 235
Medical history


Age of onset, y, median (range) 3.8 (0.213.2) 4.6 (0.812.6) 4.6 (0.515.3) 170


Duration of symptoms, mo, median (range) 12 (248) 12 (272) 12 (236) 170
Positive family history, n (%) 15 (19.5) 14 (17.7) 10 (12.7) 235
Use of PEG at the time of referral, n (%) 23 (29.9) 22 (27.8) 13 (16.5) 235
Outcome measures
Fecal incontinence, n (%) 28 (36.4) 31 (39.2) 33 (41.8) 235
Fecal incontinence per week, mean (SD) 7.3 (5.8) 5.2 (4.6) 7.1 (6.3) 235
<3 defecations per week, n (%) 21 (27.3) 10 (12.7) 17 (21.5) 235
Stool frequency per week, mean (SD) 5.2 (4.0) 6.4 (4.6) 5.8 (4.5) 235
Painful defecation, n (%) 61 (79.2) 53 (67.1) 56 (70.9) 235
Large diameter stools, n (%) 52 (67.5) 51 (64.6) 56 (70.8) 235
Stool withholding behavior, n (%) 54 (70.1) 55 (69.6) 59 (74.7) 235
Rome III criteria, median (p2575) 3 (33) 3 (33) 3 (33) 235
Physical examination
Rectal fecal impaction, n (%) 49 (63.6) 52 (65.8) 48 (60.8) 225y
Additional clinical characteristics
Abdominal pain, n (%) 56 (72.7) 56 (70.9) 63 (79.7) 235
Day-time urinary incontinence, n (%) 6 (7.8) 10 (12.7) 9 (11.4) 235
Night-time urinary incontinence, n (%) 6 (7.8) 4 (5.1) 10 (12.7) 235
Day- and night-time urinary incontinence, n (%) 12 (15.6) 14 (17.7) 16 (20.3) 235
Urinary tract infection, n (%) 8 (10.4) 8 (10.1) 10 (12.7) 235

p2575 percentile 25% to 75%; PEG polyethylene glycol 3350; SD standard deviation.


Missing characteristics were unknown to parents.
y
Rectal examination not performed because the child was too frightened to cooperate.

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 JPGN  Volume 62, Number 4, April 2016 Follow-up in Childhood Functional Constipation

TABLE 2. Effect of follow-up on primary outcome: number of successfully treated children after 3, 6, and 12 months

Control group Phone group Web group

Outcome n (%) OR n (%) P OR (95% CI) n (%) P OR (95% CI)

Successfully treated
3 mo 46 (59.7) 1 (ref) 50 (63.3) 0.65 1.16 (0.612.22) 63 (79.7) 0.007 2.65 (1.305.41)
6 mo 49 (63.6) 1 (ref) 51 (64.6) 0.90 1.04 (0.542.00) 63 (79.7) 0.03 2.25 (1.094.62)
12 mo 56 (72.7) 1 (ref) 54 (68.4) 0.55 0.81 (0.411.62) 62 (78.5) 0.40 1.37 (0.662.85)
Successfully treatedy
3 mo 46 (59.7) 1 (ref) 50 (63.3) 0.65 1.16 (0.612.22) 63 (79.7) 0.007 2.65 (1.305.41)
6 mo 48 (62.3) 1 (ref) 50 (63.3) 0.90 1.04 (0.541.99) 60 (75.9) 0.07 1.91 (0.963.81)
12 mo 48 (62.3) 1 (ref) 50 (63.3) 0.90 1.04 (0.541.99) 54 (68.4) 0.43 1.31 (0.672.53)

CI confidence intervals; OR odds ratio.

Intention-to-treat analyses with last-observation-carried-forward imputation of dropout primary outcome data.
y
Intention-to-treat analyses with imputation of dropout by negative outcome data.

Primary Outcomes
Primary outcome are shown in Table 2. We only found
significant difference in prevalence of successfully treated children
between the Web group and the control group with rates of 79.7%
(63/79) versus 59.7% (46/77) after 3 months and 79.7% (63/79)
versus 63.6% (49/77) after 6 months, respectively (P 0.007 and
P 0.03). After 12 months, no difference was found between any
intervention groups. At 12 months, successful treatment as the last
known status was recorded in 7 patients who dropped out from the
control group, 3 from the phone group, and 5 from Web group. By
imputation, assuming that all those who dropped out were con-
stipated caused the difference found at 6 months to dissolve but did
not change the statistical significance levels between any interven-
tion groups after 3 and 12 months.
Secondary Outcomes
Secondary outcomes are presented in Table 3. Overall,
34.9% (82/235) of the families used 1 extra phone consultation
during the 12-month follow-up. Significantly, more families from
the Web group compared with the control group used extra phone
calls (44.3%, 35/79) (28.6%, 22/77) (P 0.04), whereas no differ-
ence was found between the phone and Web groups (P 0.10).
During the first 3 months, 45.5% (30/66) of the extra phone contacts
originated from the Web group, whereas 28.8% (19/66) and 25.8%
(17/66) originated from the control and phone groups, respectively
(Web vs control P 0.05, Web vs phone P 0.02, control vs phone
P 0.70). No difference in extra phone contacts was found from 3
to 6 months or from 6 to 12 months (data not shown). Surprisingly,
the number of requests for extra phone consultations in the Web
group was seen in 46.5% (20/43) of those who used the Web site and
41.7% (15/36) in those who never logged in (P 0.67). Further-
more, we found no difference in the number of successfully treated
children between those families who used the Web site and those
who never logged in (74.4%, 32/43) (83.3%, 30/36) (P 0.34).
Likewise, overall, we found no difference in the number of suc-
cessfully treated children between those families who used extra
phone consultations and those who never had extra consultations
(64.0%, 110/172) (68.3%, 43/63) (P 0.54). When looking at the

TABLE 3. Effect of follow-up on secondary outcomes after 12 months: number of extra phone consultations, relapse of constipation, fecal
incontinence, and laxative use

Control group Phone group Web group

Outcome n (%) OR (Ref) n (%) P OR (95% CI) n (%) P OR (95% CI)

Extra phone consultations

Total 22/77 (28.6) 1 25/79 (31.6) 0.68 1.16 (0.582.30) 35/79 (44.3) 0.04 1.99 (1.023.86)
Successfully treated 2/22 (9.1) 1 10/25 (40.0) 0.02 0.15 (0.030.79) 8/35 (22.9) 0.20 0.34 (0.11.2)
Relapse
Total 12/77 (15.6) 1 15/79 (19.0) 0.58 1.27 (0.552.92) 11/79 (13.9) 0.77 0.88 (0.362.13)


Fecal incontinence
Successfully treatedy 7/77 (9.1) 1 3/79 (3.8) 0.33z 1/79 (1.3) 0.06z
Persistently constipated 10/77 (13.0)jj 1 17/79 (21.5)jj 0.16 1.84 (0.784.32) 12/79 (15.6) 0.69 1.20 (0.492.97)
Use of PEG
Successfully treated 23/56 (41.1) 1 14/54 (25.9) 0.10 0.50 (0.221.13) 21/62 (33.9) 0.42 0.73 (0.351.55)
Persistently constipated 11/21 (52.4) 1 15/25 (60.0) 0.60 1.36 (0.424.40) 10/17 (58.8) 0.69 1.30 (0.364.72)

CI confidence intervals; FC functional constipation; OR odds ratio; PEG polyethylene glycol.

One or more fecal incontinence episodes per week.
y
Without additional symptoms of FC.
z
Fisher exact test.

Without additional symptoms of FC.
jj
One child from the control group and 2 from the phone group, who did not have fecal incontinence at inclusion, developed fecal incontinence that persisted
after 12 months.

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 Modin et al
individual intervention groups, however, successful treatment
results were more often seen in children using extra phone con-
sultations in the phone group. Fecal incontinence was 1 of the
symptoms in 50% (19/38) of the relapse cases, and 23.7% (9/38) of
patients undergoing PEG treatment discontinued before 12 months.
Overall, 39.1% (92/235) of the children presented with fecal
incontinence at inclusion, and 4.7% (11/235) of the children
continued to have fecal incontinence as the only symptom. Thus,
according to the Rome III criteria, they were no longer constipated.
After 3 months, fecal incontinence was seen in 8.8% (7/79),
1.3% (1/77), and 2.5% (2/79) of the successfully treated children
from the Web, control, and phone groups, respectively (Web vs
control, P 0.06; Web vs phone, P 0.17; control vs phone,
P 1.0). Conversely, after 12 months, fecal incontinence was
reported in 9.1% (7/77), 3.8% (3/79), and 1.3% (1/79) of the
successfully treated children from the control, phone, and Web
groups, respectively (Web vs control, P 0.06; Web vs phone,
P 0.62; control vs phone, P 0.33); thus, 63.6% (49/77), 67.1%
(53/79), and 74.7% (59/79) were without any complaints after 12
months with no statistical difference between any groups. Success-
fully treated children, with fecal incontinence as their only symp-
tom, had significantly fewer episodes of incontinence compared
with the 39 persistently constipated children with fecal incontinence
(1 episode/week [range 17] vs 4 episodes/week [range 121];
P 0.02). The use of PEG after 12 months was seen in 41.1% (23/
56), 25.9% (14/54), and 33.9% (21/62) of the successfully treated
children from the Web, control, and phone groups, respectively.
Overall, there was no difference in the continued use of PEG after 3,
6, and 12 months between the 3 groups (data not shown). Persistent
relapse of constipation after 12 months was present in 16.2% (38/
235) of the children. There was no difference between the control
(15.6% [12/77]), phone (19.0% [15/79]), and Web groups (13.9%
[11/79]; P 0.678), respectively.
DISCUSSION
The present study showed that follow-up by self-motivated
access to Web-based information during the treatment of FC seems
to induce faster short-term recovery compared with no preplanned
follow-up or follow-up by health carepromoted phone consul-
tations. Making an access point available and encouraged self-
management behavior rather than making preplanned arrange-
ments for follow-up seems to empower parents in the Web group
to take active participation in the management of FC. Thus, it does
not seem as if the use of Web information or extra phone consul-
tations in itself makes a difference but instead, the incitement to
take action if needed induced a more proactive behavior in the
Web group.
So far, the few studies regarding follow-up of the treatment
of childhood FC have been centered on nurse-led care (810,16).
The findings by Burnett et al (9) are in accordance with our finding
regarding the identification of follow-up as an important part of the
treatment algorithm for FC. It could be argued that the increased
number of additional phone contacts in the Web group during the
first 3 months was because of failure of the intervention. The
follow-up of both the Web and control groups, however, was left to
the parents discretion. Yet, the Web group was encouraged to take
active participation and responsibility in the treatment manage-
ment by access to a Web site containing the same information as
given at inclusion on both constipation and treatment. Thus, this
group responded by being more active in the treatment manage-
ment compared with the control group by using extra phone
consultations more often. Consequently, it is not likely that the
additional phone contacts in the Web group were because of
ineffectiveness of the Web site intervention because only half
598
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JPGN  Volume 62, Number 4, April 2016
of the parents in the Web group used the Web site; furthermore, the
control group acted more passively in treatment management.
Rather, the option of Web access incentivized the parents to
participate actively in the treatment of their child independently
of the use of Web information. Furthermore, we found no effect of
Web use on the treatment outcome within the Web group because
no difference in the number of successfully treated children was
found between children who had used the Web site and children
who did not. In addition, we found no difference between children
who used extra phone consultations and those who did not, which
indicates that something other than pure health information and
treatment guidance explains the difference between the groups.
Only sparse evidence on health care providerdelivered
adherence promotion interventions for children is available, and
the majority of literature involves children with asthma and
younger children (17). The need for intervention studies, however,
is obviously needed to clarify which intervention format (eg, phone
interventions and face-to-face consultations) and content (eg,
information, education, and behavior therapy) are efficient. In a
study in diabetes self-management in adults, participation led to
greater self-efficacy in patients and to better health outcomes (18).
Although the treatment of childhood FC to a large extent relays
on participation of parents to manage daily laxative treatment and
their continuous support to adequate toilet behavior, facilitating
self-management and active participation to parents should be
considered an important clinical skill. Providing resources for
families to choose actively when they need information, with
parents playing an active role in the treatment of their children
(Web group), seems to facilitate prompt treatment success.
Overall, we found an increased rate of successfully treated
children compared with the systematic review by Pijpers et al (19)
who reported a recovery rate after 6 to 12 months of 60.6%. This
difference may be the consequence of the study population,
because the patients originate from secondary care and may suffer
from a milder form of FC compared with children from tertiary
care. The overall increased recovery rate was also reflected in the
recovery from fecal incontinence. Fecal incontinence at inclusion
seemed to follow a pattern in which cessation of constipation was
preceded by a period of fecal incontinence as the single symptom
combined with a progressive decline in incontinence episodes.
This pattern was prone to start earlier in the Web group (during the
first 3 months), whereas children with no scheduled follow-up only
started to resolve constipation and showed fecal incontinence as
the single symptom after 12 months. This accelerated treatment
course in the Web group could be initiated by a more active self-
management behavior through the use of additional phone con-
sultations, whereas the more passive health carepromoted fol-
low-up, as applied in the phone group, did not stimulate additional
phone contacts.
Research in various pediatric chronic health conditions,
including asthma, has shown that multicomponent interventions
have obvious effects on adherence behaviors (20). Contrary to our
expectations, treatment success seemed to be equal between the 3
intervention groups after 12 months. Our expectation was that the
phone group with health care providerdelivered phone contacts
could be regarded as the part of a multicomponent intervention. It
is likely that the 3 scheduled data collection visits after 3, 6, and
12 months, however, influenced the compliance to the applied
treatment regimen and diluted the positive effect seen in the Web
group. This hypothesis is supported by the fact that the main
difference in effect was seen before 3 months. In addition, we
assumed that the 3 scheduled data collection visits increased the
treatment effect in all the 3 groups and may reduce the com-
menced incentive to further self-management in the Web group.
Thus, we argue that it is likely that the difference between the
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 JPGN  Volume 62, Number 4, April 2016
3 intervention groups would have been larger without the 3
scheduled data collection visits. Because relapses are generally
high when treating FC, omitting follow-up after the first visit
would not be ethical. Hence, we cannot conclude that children can
settle with only 1 visit in combination with access to Web
information to achieve fast recovery. In contrast, clear infor-
mation to the parents and ready access to relevant health care
personnel on the parents discretion either by face-to-face or
phone consultations is essential.
These findings underline the importance of not only focus-
ing on the administration of laxative treatment, but also on how to
implement the appropriate follow-up to achieve treatment success.
The small number of specialized staff conducting the follow-up
and subsequent visits could pose a challenge to generalize the
results to daily clinical practice. When it comes to comparisons
between the 3 follow-up regimens, the limited staff, however,
minimizes information bias. Still, the increased focus on standar-
dized delivery of information and education could contribute to
increased adherence to treatment as shown by a high overall
remission rate. Because treatment regimens were carried out in
accordance with internationally accepted guidelines, we, however,
consider that the results are widely applicable. Moreover, the study
was nonblinded both during data collection and interpretation. To
reduce the risk of bias caused by the nonblinded design, the
randomization was performed at the end of each inclusion visit,
thereby making baseline data collection, information, and edu-
cation independent of the allocated intervention. Moreover, the use
of standardized outcome measures in combination with clinical
examination and face-to-face interviews contribute to outcome
measures of the highest possible standard. Finally, sensitivity
analysis implied that successfully treated children dropouts
affected the study outcomes. To meet this challenge, we performed
statistical analysis with imputation of the last-information-carried-
forward. Because the results point at parental factors and treatment
management behavior as essential components in achieving treat-
ment success, rather than merely application of standard follow-up
regimes, our results urge future studies to uncover the parental
factors that determine desirable health care behavior for the benefit
of both the child and the health care system. Despite the apparent
presence of limitations, we believe the study has important
strengths comprising a large sample size and a low number of
eligible families declining participation. Little is known about
decision-making and self-management behaviors in children (21).
Because parents are an essential part of treating childhood FC, self-
management behavior both in parents and children may be an
important area worth giving attention when dealing with the
treatment of FC in children.
Based on our study results, self-motivated access to Web-
based information seems to induce faster short-term recovery
during the treatment of FC. Furthermore, the self-motivated concept
initiated by the access to Web based information and education
looks as if it promotes responsibility for the treatment. Thus, active
patient participation for example through Web-based information
and education rather than health carepromoted follow-up could be
a step toward a more effective follow-up routine, at least short-term.
The results of our study indicate the need for future research with
focus on self-management behavior in both parents and children
to clarify the role of patient empowerment in the treatment of
childhood FC.
www.jpgn.org
Copyright 2016 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.
Follow-up in Childhood Functional Constipation
Acknowledgment: The authors thank Gitte Deinbaek for help
with data collection during follow-up.
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