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.

….indeed, the criteria were designed to be used as diagnostic tools

What are we talking about?

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, aminotrasfer. Urinalysis, tTG for all

Acceptable abdomen US

Anti-H2 block. PPI, acceptable domperidone

Functional abdominal pain

Blood cell count ESR, stool exa. tTG for all

Acceptable abdomen US

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 Blood cell count ESR, stool exa. tTG for all

none No drug accepted but 1 empirical dose of tinidazole

Cyclic vomiting syndrome

Serum glucose, urea, aminotra. Amylase, lipase, metabolic panel

Ref. to Center for upper X-ray series and endoscopy, brain MRI, Ab. US

No drug, a trial with gastric acid inhib. or lorazepam allowed

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]).

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 $

Comparison of costs between two studies utilizing different diagnostic approach

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, aminotrasfer. Urinalysis, tTG H. pylori

Acceptable abdomen US

Anti-H2 block. PPI, acceptable domperidone

Functional abdominal pain

Blood cell count ESR, stool exa. tTG for all

Acceptable abdomen US

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 Blood cell count ESR, stool exa. tTG for all

none No drug accepted but 1 empirical dose of tinidazole

Cyclic vomiting syndrome

Serum glucose, urea, aminotra. Amylase, lipase, metabolic panel

Ref. to Center for upper X-ray series and endoscopy, brain MRI, Ab. US

No drug, a trial with gastric acid inhib. or lorazepam allowed

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?