1. 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.

2. …..We should focus on identifying ‘‘key’’ features or symptoms that characterize functional pain, and promote a positive diagnosis rather than a diagnosis of exclusion.

3. …. indeed, the criteria were designed to be used as diagnostic tools What are we talking about?

4. 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

5. Is it possible to save money maintaining a high diagnostic accuracy and cost/effective treatment?

7. 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.

8. 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

9. Pediatric FGID in Rome II classification

10. 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

11. Definition of compliance with diagnostic and therapeutic protocols DisordersLab. Exam.Instrum. Exa.Drugs Infant regurgitation none Functional Constipation 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

12. Definition of compliance with diagnostic and therapeutic protocols DisordersLab. Exam.Instrum. Exa.Drugs IBSBlood cell count ESR, stool exa. tTG for all, optional fecal calprotectine In presence of red flags: colonoscopy with biopsy Macrogol in presence of constipation

13. 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

14. Definition of compliance with diagnostic and therapeutic protocols DisordersLab. Exam.Instrum. Exa.Drugs IBSBlood 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 noneNo 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

15. 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

16. 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]).

17. AuthorDhroove et al. Primavera et al. Patient number243261 Laboratory examinations92%42% GI contras radiograph studies 38.5%1.9% Abdominal US23%13.7% CT/MRI7%0.7% Upper GI endoscopy33.6%0.7% Colonoscopy17%0.38% Total costs744726 $ Costs/patient6104 $ Comparison of costs between two studies utilizing different diagnostic approach

18. Is it possible to replicate this study in other settings with higher prevalence of organic diseases? DisordersLab. Exam.Instrum. Exa.Drugs Infant regurgitation none Functional Constipation 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

19. 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

20. 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

21. Is it possible to replicate this study in other settings with higher prevalence of organic diseases? DisordersLab. Exam.Instrum. Exa.Drugs IBSBlood 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 noneNo 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

22. 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?

23. 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

24. 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?