What are we talking about?
Functional gastrointestinal disorders (FGIDs)
are defined as a variable combination of chronic
or recurrent gastrointestinal symptoms not
explained by structural or biochemical
abnormalities.
…..We should focus on identifying ‘‘key’’
features or symptoms that characterize
functional pain, and promote a
positive diagnosis rather than a diagnosis
of exclusion.
What are we talking about?
….indeed, the criteria were designed to
be used as diagnostic tools
243 children (4-18 yr-old): 122 Pain Predominant-FGID
All underwent diagnostic investigations:
92% Lab examinations; 38.5% GI contrast radiograph studies;
23% Abdominal US; 7% CT/MRI; 33.6% Upper GI endoscopy;
17% colonoscopy
Total costs: 744726 $
Cost/patient: 6104 $
JPGN 2010
Is it possible to save money
maintaining a high diagnostic
accuracy and cost/effective
treatment?
AIMS:
• To demonstrate that functional gastrointestinal
disorders (FGIDs) can be diagnosed in a
positive fashion and managed by family
pediatricians (FPs);
• to assess the compliance of FPs with a
predefined diagnostic/therapeutic protocol for
managing FGIDs in order to evaluate efficacy of
continuing medical education;
• to evaluate the success of reassurance by using
a biopsychosocial model in comparison to drug
treatment in an open-label, nonrandomized
study.
Methods
• Twenty-one FPs from Western Sicily
participated in the study
• Seminar held by a senior gastroenterologist
to discuss Rome criteria and a validated
questionnaire
• During a 3-month period FPs completed the
questionnaire for all consecutive 1d-14yr old
children who fulfilled Rome II criteria
recording all children examined per day
Pediatric FGID in Rome II classification
Methods
• Twenty-one FPs from Western Sicily
participated in the study
• Seminar held by a senior gastroenterologist
to discuss Rome criteria and a validated
questionnaire
• During a 3-month period FPs completed the
questionnaire for all consecutive 1d-14yr old
children who fulfilled Rome II criteria
recording all children examined per day
• FPs were asked to follow the
diagnostic/therapeutic protocol and in order
to assess their compliance to record
investigations and treatment prescribed
Definition of compliance with diagnostic
and therapeutic protocols
Disorders
Lab. Exam.
Instrum. Exa.
Drugs
Infant
regurgitation
none
none
none
Functional
Constipation
none
none
Macrogol for
impaction and
maintenance
(or lactulose)
Functional
dyspepsia
Amylase, lipase, Acceptable
aminotrasfer.
abdomen US
Urinalysis, tTG
for all
Anti-H2 block.
PPI, acceptable
domperidone
Functional
abdominal pain
Blood cell count Acceptable
ESR, stool exa. abdomen US
tTG for all
No drug
Definition of compliance with diagnostic
and therapeutic protocols
Disorders
Lab. Exam.
Instrum. Exa.
Drugs
IBS
Blood cell count
ESR, stool exa.
tTG for all,
optional fecal
calprotectine
In presence of
red flags:
colonoscopy
with biopsy
Macrogol in
presence of
constipation
Red flags
•
•
•
•
•
•
•
•
•
Epigastric or lower abdominal pain
Dysphagia
Arthritis or unexplained fever
Vomiting (once a week or more)
Gastrointestinal bleeding
Diarrhea and weight loss
Poor growth or pubertal delay
Perianal lesions
Family history of CD, IBD or peptic ulcer
Definition of compliance with diagnostic
and therapeutic protocols
Disorders
Lab. Exam.
Instrum. Exa.
Drugs
IBS
Blood cell count
ESR, stool exa.
tTG for all,
optional fecal
calprotectine
In presence of
red flags:
colonoscopy
with biopsy
Macrogol in
presence of
constipation
Functional
diarrhea
Not mandatory none
Blood cell count
ESR, stool exa.
tTG for all
No drug
accepted but 1
empirical dose
of tinidazole
Cyclic vomiting
syndrome
Serum glucose,
urea, aminotra.
Amylase, lipase,
metabolic panel
No drug, a trial
with gastric
acid inhib. or
lorazepam
allowed
Ref. to Center
for upper Xray series and
endoscopy,
brain MRI, Ab.
US
Methods
• Each child who received a diagnosis of FGIDs
was then re-evaluated through a standard
sheet, by the same pediatrician after 1, 6 and
12 months to determine if there had been a
change in diagnosis and to evaluate symptoms
• Gold standard for diagnosis was clinical status
at 12-month follow-up
RESULTS
• A total of 9291 patients, aged birth to 14 years,
were prospectively enrolled; 261 met Rome II
criteria and were included in the study.
• In all cases but 4, diagnosis of FGIDs was
confirmed at the end of follow-up (98.4%).
• Average compliance of FPs was 80%.
• Among 56 patients treated only with the
explanation of symptom and reassurance, 52
(92.8%) have reported success, in comparison
with 26 of 35 patients (74.3%) treated with drugs
(odds ratio: 4.5 [95% confidence interval: 1.3–
16]).
Comparison of costs between two studies
utilizing different diagnostic approach
Author
Dhroove
et al.
Primavera
et al.
Patient number
243
261
Laboratory examinations
92%
42%
GI contras radiograph
studies
38.5%
1.9%
Abdominal US
23%
13.7%
CT/MRI
7%
0.7%
Upper GI endoscopy
33.6%
0.7%
Colonoscopy
17%
0.38%
Total costs
744726 $
Costs/patient
6104 $
Is it possible to replicate this study in
other settings with higher prevalence of
organic diseases?
Disorders
Lab. Exam.
Instrum. Exa.
Drugs
Infant
regurgitation
none
none
none
Functional
Constipation
none
none
Macrogol for
impaction and
maintenance
(or lactulose
Functional
dyspepsia
Amylase, lipase, Acceptable
aminotrasfer.
abdomen US
Urinalysis, tTG
H. pylori
Anti-H2 block.
PPI, acceptable
domperidone
Functional
abdominal pain
Blood cell count Acceptable
ESR, stool exa. abdomen US
tTG for all
No drug
80 consecutive Chinese children ages 7 to 16 with FD
2 groups: without any alarm features
wth alarm features
All underwent upper endoscopy
Alarm features relevant to dyspepsia:
-gastrointestinal blood loss
- dysphagia
-persistent vomiting, persistent right upper quadrant
pain,
-nocturnal pain
-family history of PUD and involuntary weight loss
We believe that it may even be more cost-effective to
perform screening tests of H pylori on male patients
The study does not suggest that a negative endoscopy
improves the outcome of children with FGIDs
Is it possible to replicate this study in
other settings with higher prevalence of
organic diseases?
Disorders
Lab. Exam.
Instrum. Exa.
Drugs
IBS
Blood cell count
ESR, stool exa.
tTG for all,
optional fecal
calprotectine
In presence of
red flags:
colonoscopy
with biopsy
Macrogol in
presence of
constipation
Functional
diarrhea
Not mandatory none
Blood cell count
ESR, stool exa.
tTG for all
No drug
accepted but 1
empirical dose
of tinidazole
Cyclic vomiting
syndrome
Serum glucose,
urea, aminotra.
Amylase, lipase,
metabolic panel
No drug, a trial
with gastric
acid inhib. or
lorazepam
allowed
Ref. to Center
for upper Xray series and
endoscopy,
brain MRI, Ab.
US
Is it possible to replicate this study in
other settings with higher prevalence of
organic diseases?
Is it possible or necessary to create a
network with family pediatricians or
general practioners?
OBJECTIVE—The objectives of this study were to (1) compare the
cost of medical evaluation for children with functional abdominal pain
or irritable bowel syndrome brought to a pediatric gastroenterologist
versus children who remained in the care of their pediatrician
Is it possible to replicate this study in
other settings with higher prevalence of
organic diseases?
Is it possible or necessary to create a
network with family pediatricians or
general practioners?
Is it possible to apply the protocol for
out or in-patients in the hospital?