Impact of the new ESPGHAN diagnostic criteria for celiac disease in the Mediterranean area

1. Impact of the new ESPGHAN diagnostic criteria for celiac disease in the Mediterranean area The Mediterranean Network for Celiac Disease V Progress Meeting - Istanbul, June 30th 2012 Francesca Tucci

2. CLINICAL CD GUIDELINES JPGN 2012;54: 136–160

3. AIM OF THIS CROSS SECTIONAL SURVEY • To obtain a picture of the diagnostic facilities available in the 16 CD reference centers of the Mediterranean Basin • To determine where the new ESPGHAN criteria could be applied and on what percentage of patients • To estimates the likelihood of having a diagnosis of CD, both with and without endoscopy/histology results, to determine where the new criteria can be applied

4. We analyzed 831 CD cases from the 16 CD reference centers of the Mediterranean Basin

5. Clinical, histological and laboratory data were collected through a standardized form

6. Missing Data

7. A SIMPLE SCORING SYSTEM FOR THE DIAGNOSIS OF CD • The aims of the scoring system are as follows: • To positively diagnose coeliac disease at the initial assessment and be able to accept a diagnosis made in the past with biopsy • To simplify the diagnosis of CD in patients with obvious findings • To protect against overdiagnosis when only nonspecific findings are present • To compare by a standardized criteria the diagnostic capacities of each centre we computed the SAGE score for each case, by summing the clinical features to the serology and Histology data and adding the HLA data, when available

8. SAGE score

9. Discussion • This cross-sectional study provides the first picture of the “pattern” of CD in these countries and of the diagnostic capabilities available in the reference centers evaluated • Most cases were symptomatic and most showed the classical symptoms • tTGA assay is available in most of the countries evaluated, but it needs standardization in more than one-third of countries • We applied the SAGE score to evaluate the diagnostic chances of an individual having CD, almost all cases had a diagnostic score (> 4) when biopsy was available, but the vast majority of them (85%) would have diagnostic score without biopsy only if HLA testing were available • Biopsy is generally available, but it is clear that many centers will require support in order to standardize the histological procedures. Biopsy is an obstacle to the dissemination

10. Referee(s)' Comments to Authors JPGN Reviewer #1 The objective set for the study was "to obtain an objective picture of the facilities available for CD diagnosis in the reference centers of MEDICEL countries to determine where the new ESPGHAN diagnostic criteria could be applied and on what percentage of patients". This suggests a study that will contrast a certain number of tests to be done for diagnosis ("current" against "new" criteria), defined as "diagnostic criteria" and the facilities available, all of which will lead to calculate how many centers are able to adequately diagnose CD in the region assessed. Authors are not explicit about what they are comparing when they say "current criteria" (ESPGHAN 1990) and "new criteria". This latter refers to an important initiative of some researchers who have proposed a protocol i.e., a protocol to be tested but that by no means represents accepted new criteria. Rather this refers to exceptional cases in which a small intestinal biopsy can be not necessary. In statistical analysis authors declare "comparison between groups"; comparison should be between one set of criteria against the other and not between groups. WJG Reviewer#1 The authors seek to provides the first picture of the pattern of coeliac disease in the Mediterranean basin and to identify the diagnostic capabilities available in this area. They appear to have succeeded in this aim and I cannot make any suggestions or revisions to improve what is a very well written paper Reviewer#2 The data presented here has serious limitations. The data is quite heterogenous and retrospective in nature. 3 main parameters like tTGA assay biopsy and HLA have not been performed in all the patients. There is gross ununiformity of tTGA and biopsy reporting. The aim of the study has not been properly addressed

11. Need a change: Data file • To revise the data file in order to fill out our data • To have, for each country  center, COMPLETE  cases  for the following: Clinical information Age SexTgaseBiopsies

12. Need a change: Serology tests • Type of test used: • What tTG Kit each center use? • Are the cut-off value standardized? • Biological samples: Availability of storage sera

13. Need a change: Biopsy criteria • Criteria for assessment of biopsy: • Is Marsh Oberhuber criteria a standardized form? • Does each center use it?

14. HLA For HLA we will consider the differences above the country resources Biological samples: Availability of DNA Proposal: a DNA-bank to type all missing data (from saliva/blood)

15. How can we improve this work? • We have worked for more than a year • Deadline: end of July • Next journal: Digestive and Liver Disease