A point-of-care test for facing the burden of undiagnosed celiac disease in the Mediterranean area: a pragmatic design study.

BACKGROUND: We aimed at assessing the factors that can influence results of the dissemination of an already validated, new generation commercial Point-of-Care Test (POCT) for detecting celiac disease (CD), in the Mediterranean area, when used in settings where it was designed to be administered, especially in countries with poor resources. METHODS: Pragmatic study design. Family pediatricians at their offices in Italy, nurses and pediatricians in Slovenia and Turkey at pediatricians', schools and university primary care centers looked for CD in 3,559 (1-14 yrs), 1,480 (14-23 yrs) and 771 (1-18 yrs) asymptomatic subjects, respectively. A new generation POCT detecting IgA-tissue antitransglutaminase antibodies and IgA deficiency in a finger-tip blood drop was used. Subjects who tested positive and those suspected of having CD were referred to a Celiac Centre to undergo further investigations in order to confirm CD diagnosis. POCT Positive Predictive Value (PPV) at tertiary care (with Negative Predictive Value) and in primary care settings, and POCT and CD rates per thousand in primary care were estimated. RESULTS: At tertiary care setting, PPV of the POCT and 95% CI were 89.5 (81.3-94.3) and 90 (56-98.5) with Negative Predictive Value 98.5 (94.2-99.6) and 98.7% (92-99.8) in children and adults, respectively. In primary care settings of different countries where POCT was performed by a different number of personnel, PPV ranged from 16 to 33% and the CD and POCT rates per thousand ranged from 4.77 to 1.3 and from 31.18 to 2.59, respectively. CONCLUSIONS: Interpretation of POCT results by different personnel may influence the performance of POC but dissemination of POCT is an urgent priority to be implemented among people of countries with limited resources, such as rural populations and school children.

Clinical utility of Rome criteria managing functional gastrointestinal disorders in pediatric primary care.

OBJECTIVE: Our goals were 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 to evaluate efficacy of continuing medical education; and to evaluate the success of reassurance by using a biopsychosocial model in comparison to drug treatment in an open-label, nonrandomized study. PATIENTS AND METHODS: A total of 9291 patients, aged birth to 14 years, were prospectively enrolled during a 3-month period by 21 FPs. Follow-up was performed at 1-, 3-, and 12-month intervals. To assess compliance, after diagnosis, FPs that participated in the study were asked to comply with the diagnostic/therapeutic protocol and record investigations and treatment prescribed. RESULTS: Two hundred sixty-one patients (2.8%) 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]). CONCLUSIONS: FGIDs can be diagnosed and managed in primary care. Prospective studies in primary care allow assessment of compliance of pediatricians and implementation of what is learned in courses developed in continuing medical education. Informed reassurance and availability of FPs are more useful than over-the-counter drugs, which are often used for FGIDs.