The prevalence of functional constipation in children was unchanged after the Rome IV criteria halved the diagnosis period in Rome III

1. REGULAR ARTICLE
The prevalence of functional constipation in children was unchanged after
the Rome IV criteria halved the diagnosis period in Rome III
Edgar Jativa-Mari~no1,2
, Maritza Gisel Rivera-Valenzuela3
, Carlos Alberto Velasco-Benitez4,5
, Miguel Saps (msaps@med.miami.edu)6
1.Faculty of Medicine, Universidad Central del Ecuador, Quito, Ecuador
2.Medical Sciences PhD program, Universidad de La Frontera, Temuco, Chile
3.Functional International Digestive Epidemiological Research Survey Group
4.Department of Paediatrics, Universidad del Valle, Cali, Colombia
5.Universidad de Granada, Granada, Espa~na
6.Division of Pediatric Gastroenterology, Hepatology Nutrition, Department of Pediatrics, Miller School of Medicine, University of Miami, Miami, FL, USA
Keywords
Constipation, Defecation disorders, Diagnosis,
Functional gastrointestinal disorders, Rome IV criteria
Correspondence
M Saps, MD, Division of Pediatric Gastroenterology,
Hepatology Nutrition, Department of Pediatrics,
Miller School of Medicine, Mailman Center,
University of Miami, 1601 NW 12 AVE, Suite 3005A,
Miami, FL 33136, USA.
Tel: 305-243-3166 |
Fax: 305-243-2617 |
Email: msaps@med.miami.edu
Received
6 September 2018; revised 26 March 2019;
accepted 27 May 2019.
DOI:10.1111/apa.14880
ABSTRACT
Aim: The Rome IV criteria for the diagnosis of functional constipation are one month,
compared with two months in the Rome III criteria. Our aim was to see whether this altered
the prevalence in Ecuador by surveying school children and comparing the results to our
previous study.
Methods: A cross-sectional study was conducted in Quito, Ecuador, in 2013 two randomly
selected schools: one private and one public. Children aged 8–15 completed the Spanish
version of the Questionnaire of Paediatric Gastrointestinal Symptoms based on the Rome
IV criteria. We compared our findings with our previous 2013 study based on the Rome III
criteria.
Results: A total of 951 children (61% male) completed the Rome IV questionnaire from
June to July 2017 at a mean age of 11.2 Æ 1.8 years, and 417 children (52% male)
completed the Rome III questionnaire in June 2013 at a mean age of 12.0 Æ 1.8 years.
We found that 14.4% met the Rome IV criteria for functional constipation compared with
11.8% for the Rome III criteria (p = 0.11).
Conclusion: Modifying the time required for a diagnosis functional constipation from two
months to one month did not result in a significant difference in the prevalence.
INTRODUCTION
Functional constipation is a common diagnosis in children
and caring for them is costly and a significant burden on
healthcare services (1). Children with functional constipa-
tion have been reported to use more health services than
healthy children (2,3), and a 2009 study stated that this
disorder cost the United States more than $3.9 billion per
year (2). Many of these children had associated faecal
incontinence. Although most children with functional
constipation and faecal incontinence receive outpatient
care (4), substantial costs for caring for children who are
hospitalised have been reported (1). A study of national
trends in the United States calculated that the mean total
cost for hospitalising a child with faecal incontinence,
associated with functional constipation, was $13 252 in
2009 (1).
The diagnosis of functional constipation in children is
clinical and based on the Rome criteria. This set of
diagnostic criteria is currently on its fourth edition (Rome
IV), and the last three publications have included a
paediatric version. The diagnostic criteria for functional
constipation have varied with each edition. The Rome IV
criteria distinguish between children who have and have
not been toilet training. In addition, the time needed to fulfil
the criteria for functional constipation has been reduced
from two months to one month (5).
A systematic review of epidemiological studies of chil-
dren across the world using the Rome II and Rome III
criteria found a median prevalence of functional constipa-
tion of 12.0% (6). In 2018, Koppen et al published a
Abbreviations
CI, Confidence interval; OR, Odds ratio.
Key notes
The Rome criteria period for diagnosing functional
constipation has been reduced from two months to one
month, and we examined whether this affected the
prevalence.
A questionnaire study was conducted from June to July
2017 with 951 children aged 8–15 and compared with
a study of 417 children in June 2013.
The difference was not significant, as 14.4% met the
Rome IV criteria and 11.8% met the Rome III criteria.
©2019 Foundation Acta Pædiatrica. Published by John Wiley Sons Ltd 1
Acta Pædiatrica ISSN 0803-5253

2. systematic review and meta-analysis of studies, according to
the Rome III criteria, which found a pooled prevalence of
9.5% in children worldwide (7). Those studies suggested
that changes in the diagnostic criteria could result in
changes in prevalence. It would be reasonable to expect
that the changes to the criteria that appear in Rome IV
could have changed the prevalence of functional constipa-
tion in children. The aim of this study was to compare the
prevalence of functional constipation and functional defe-
cation disorders in our previous study of children using the
Rome III criteria (8) and our latest study using the Rome IV
criteria. We hypothesised that the move to a less stringent
diagnostic criterion in Rome IV would result in an increase
in the prevalence of functional constipation and functional
defecation disorders when the rates were compared with
Rome III (8).
METHODS
A cross-sectional study was conducted from June to July
2017 in Quito, Ecuador. The validated English version of
the Questionnaire of Paediatric Gastrointestinal Symptoms
based on the Rome IV criteria was translated into Spanish.
In addition, the terminology was adapted to the regional
vocabulary so that it would be understood by the children
who took part. Children from a public and a private school
were given the Spanish translation of the Rome IV ques-
tionnaire on defecation disorders and the questions that
were relevant to diagnosing functional constipation are
presented in Table 1. The schools were the same in both
studies and had been randomly selected from a list of the
schools in Quito that teach all academic years in order to
include students from all age ranges. Children aged 8–15
were invited to participate. Information on the study, a
questionnaire on the child’s past medical history and a
consent form were sent to all parents. Children with
reported organic diseases were excluded from the study.
We included all subjects aged 8–15 who agreed to
participate and provided a consent form signed by their
parents. The study was explained to the students by the
research team, and they were also available in case there
were any questions when the students completed the
questionnaires, which took place during a lesson. The study
was approved by the school authorities and institutional
ethics committee of the Academic Development Depart-
ment of the Universidad Central of Ecuador.
We previously carried out and published the results of a
study of children from the same schools in Quito that was
based on the Rome III diagnostic criteria (8). That survey
was carried out in June 2013. In order to compare the
results of the current and previous study, the population
was paired by sex, age and social-economic conditions.
Children who participated in the Rome III study (8) were
not enrolled in the current study.
Statistical methods
The data from the questionnaires were saved electronically.
Age was the only numerical variable in the study and is
presented as a mean and standard deviation (SD) in Table 2.
The t-test was used to calculate differences in the mean age
between the Rome III and Rome IV questionnaires. The
remaining variables that we considered were all binary:
whether the participants were male or female, whether they
attended the public or private and whether functional
constipation and defecation disorders were present or
absent. The differences in the proportion of the binary
variables between the Rome III study (8) and Rome IV were
tested with Fisher’s exact test. We also calculated separate
odds ratios (OR) and 95% confidence intervals (95% CI) for
each of the following binary variables: sex, age group (8–12
and 13–15 years) and type of school. A p value of 0.05 was
considered statistically significant.
RESULTS
The data for the Rome IV questionnaire were collected from
June to July 2017 and were compared with the data
collected in June 2013 for our previous survey based on
the Rome II criteria (8). A total of 1030 schoolchildren
ranging from eight to 15 years of age were invited to
participate in latest study, and 951 (92.3%) met the
inclusion criteria and completed the Rome IV
Table 1 The questions the participants were asked in both studies to reach
a diagnosis of functional constipation
Self-report format for children and adolescent to diagnose Functional
constipation (adapted from the Questionnaire of Pediatric Gastrointestinal
Symptoms, Walker, Caplan-Dover, Rasquin-Weber, 2000 (11))
Section B. Belly Aches and Abdominal Pain Around and
Below the Belly Button
In the last month, on how many days did you have a belly ache,
stomach ache or pain in the area around or below the belly button?
How long have you had a belly ache, stomach ache or pain around or
below your belly button?
In the past month, when you had a belly ache, stomach ache or pain
around or below the belly button, how often:
Did the belly ache, stomach ache or pain happen around the time you
pooped?
Were your poops softer and more mushy or watery than usual?
Were your poops harder or lumpier than usual?
Did you poop more often than usual?
Did you have poop less often than usual?
Are you taking medications for constipation or hard stools?
Do you ever get severe intense pain around the belly button that hurts so
much it makes you stop everything that you are doing?
Section C. Bowel Movements (‘Poop’, ‘Stool’, ‘Number 2’)
In the last month, how often did you usually poop?
Look at the Bristol Stool Chart above. In the last month, what was
your poop usually like?
In the last month, did it hurt when you had a poop?
In the last month, did you have a poop that was so big that it clogged
the toilet?
In the last month, while at home, how often did you try to hold
in a poop?
Did a doctor or nurse ever examine you and say that you had a
huge poop inside?
In the last month, how often did you poop in your pants?
2 ©2019 Foundation Acta Pædiatrica. Published by John Wiley Sons Ltd
Functional constipation in children Jativa-Mari~no et al.

3. questionnaire. The participants were predominantly from
the public school (53.2%), and the majority were male
(60.7%). Subjects were subdivided into two age categories,
8–12 years (68.3%) and 13–15 years (31.7%). The mean age
of participants was 11.2 Æ 1.8 years. Figure 1 provides a
flow chart of the current study. There were statistically
significant differences between the two studies in the age of
the participants, whether they were at private or public
school and their gender (Table 2).
When we combined all the functional gastrointestinal
disorders, we found a prevalence of 22.3%, for Rome IV,
which was similar to the 22.8% (p = 0.44) found using the
Rome III criteria (8). For all functional defecation disor-
ders, the prevalence was 14.4% based on Rome IV, which
was higher than the 12.0%. found in our previous study (8),
but not significantly different (p = 0.18). All the children
with defecation disorders had functional constipation.
None of them met the criteria for functional non-retentive
faecal incontinence, compared with 0.2% of the children in
our previous study (8), but the difference was not signifi-
cant. No significant differences in sex, age or type of school
between children with and without functional constipation
were found in the current study (Table 3).
DISCUSSION
This was the first epidemiological study conducted in Latin
America that was specifically designed to assess the preva-
lence of functional constipation in children using the Rome
IV criteria. The prevalence of functional constipation and
functional non-retentive faecal incontinence found in our
study was within the range of a systematic review and meta-
analysis on defecation disorders in children that was
published in 2018 and used the Rome III and Rome IV
criteria for diagnosis (7). That study found a pooled
prevalence of functional constipation of 9.5% (range 0.5–
0.32%) and a pooled prevalence of functional non-retentive
faecal incontinence of 0.4% (range 0.0–1.8%). The similarity
in results between this meta-analysis and our current study
gives further credence to our data.
The results of this study contradicted our hypothesis.
Based on the Rome III criteria, 11.8% of the children were
diagnosed with functional constipation while 14.4% of
children met this diagnosis according to the Rome IV criteria.
The change to a less rigorous time criteria, from two months
to one month, resulted in a higher prevalence of functional
constipation, but the differences in prevalence between both
studies did not reach significance. A possible likely explana-
tion for this is that the symptoms of functional constipation
are present for more than one month before patients seek
medical attention. For instance, the previous time frame
criteria appropriately captured most children with this
disorder. However, this does not imply that the changes in
the Rome IV criteria were not being followed, as they were
not changed for epidemiological reasons, but to prompt the
earlier diagnosis and treatment of functional constipation in
order to improve the outcome and prognosis of these patients
(5,9). Studies have shown that children with a shorter
duration of symptoms had better treatment outcomes (9).
The large percentages of children with functional consti-
pation found in both this study and our previous study (8)
underline the importance of this condition in children. The
median age at the onset of symptoms was 2.3 years (10).
The fact that such a high prevalence of functional
Table 2 Characteristics of the children enrolled in Rome III and Rome IV studies
Rome III Rome IV
p valuen = 417 n = 951
Mean age 12.0 Æ 1.8 11.2 Æ 1.8 0.0001
Sex (male) 51.6% 60.7% 0.001
School (public) 61.6% 53.2% 0.002
Functional defecation disorders 12.0% 14.4% 0.18
Functional constipation 11.8% 14.4% 0.11
ELIGIBLE/INVITED
n = 1030
ENROLLED
n = 992
Total 992/1030 (96.3%)
EXCLUDED
n = 41
9 gastritis
13 organic constipation
3 seizure disorder
15 renal problems
1 Down syndrome
Total 41/992 (4.1%)
COMPLETED STUDY
n = 951
Total 951/1030 (92.3%)
Figure 1 Flow chart of enrolled and included children in Rome IV study.
Table 3 Comparison of children with and without functional constipation according
to the Rome IV criteria
Rome IV
95% CI p valueFC+ FCÀ OR
Age group
School age (10–12) 100 494 1.00
Adolescent (13–15) 37 245 0.74 0.48–1.13 0.16
Sex
Female 49 296 1.00
Male 88 443 119 0.80–1.79 0.35
School
Public 69 402 1.00
Private 68 337 1.17 0.80–1.72 0.38
FC+ = with functional constipation; FCÀ = without functional constipation.
©2019 Foundation Acta Pædiatrica. Published by John Wiley Sons Ltd 3
Jativa-Mari~no et al. Functional constipation in children

4. constipation was found children well after the age when
symptoms first present indicates that the healthcare system
failed to identify or manage these children. This suggests
that larger human and budgetary resources need to be
invested in educating the country’s medical professional
about defecation disorders in children.
The fact that changes in the Rome IV criteria did not
decrease the prevalence of functional constipation is rele-
vant. Although a decrease in prevalence due to less
stringent criteria was unlikely, a lower rate of diagnosis
could have a profound effect on clinical care and research.
Decreasing the prevalence of functional constipation could
be perceived as a success for the healthcare system, which
could potentially result in much-needed clinical resources
being used for other diseases. In research terms, a lower rate
of diagnosis could lower the number of potential subjects
taking part in clinical trials on disorders that researchers
know have poor treatment outcomes (9).
The strengths of our study included the large sample size
and using a similar design in both epidemiological studies.
The only difference was the versions of the Rome criteria.
The Rome III and Rome IV epidemiological studies were
conducted in schoolchildren from the same private and
public schools, and we divided the study population into
the same age groups in order to compare our results. The
limitations of our study included the uncertainty of the
external validity of our findings. The results of the study
may not be generalisable to other groups of children. This
may be of relevance as the previously mentioned systematic
review concluded that geographical location and dietary
habits may influence the prevalence of functional consti-
pation. We did not find a statistically significant difference
in the prevalence of functional constipation based on Rome
III and Rome IV study, but the study population differed in
age, gender and the type of school they attended. This might
have had an impact on the comparison of the results.
CONCLUSION
We found that functional constipation was a common
disorder in children in Ecuador. The study suggests that
halving the timescale for diagnosis from two months in the
Rome III criteria to one month in the Rome IV criteria did
not result in significant differences in prevalence. Our
findings should be confirmed by epidemiological studies
conducted among different groups of children. Also, since
the measurement of our data relied on symptoms reported
by the participants, we cannot guarantee they were com-
pletely accurate. However, we decreased the risk of recall
bias by only asking participants to describe symptoms in the
previous month.
CONFLICTS OF INTEREST
The authors have no conflicts of interest to declare.
FINANCE
This study did not receive any specific funding.
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4 ©2019 Foundation Acta Pædiatrica. Published by John Wiley Sons Ltd
Functional constipation in children Jativa-Mari~no et al.