POCT diffusion project

M Ben Hariz. TunisiaMEDICEL. Palermo 2014

Main objective

Diffusion of POCT in schoolsChildren with growth fairlure: « small » children

Why schools

First• Because we have a good experience working

in school envirenment!

First Study : Region of Ariana

Ben Hariz M, et al. Prevalence of celiac disease in Tunisia: mass-screening study in schoolchidren. Eur J Gastroenterol hepatol 2007; 19: 687-694.

Actual proposed study : Ben Arous

Second study : Djerba

Ben Hariz M et al. Celiac disease in Tunisian children: A second screening study using a “new generation” rapid test. Immunol Invest 2013; 42: 356–368

Second

• The school is a good choice to start and succeed in our efforts to diffuse POCT

• enrollment between 6 -14 years: 100%• Large number of school doctors • generally these same doctors are also primary

care physicians lines

why “small“ child?

• Frequent situation in Tunisia (5% in our school previous study)

• The small height often motivates parents looking for a reason (little refusal to search for celiac disease)

• If celiac disease is the cause of the small height, the gluten-free diet is often followed well (unlike asymptomatic child)

selected regionGovernorate of Ben Arous

Général population: 700000Area: 761 Km2Number of schoolsNumber of pupills: 50000

DESIGN

Selected population: 50000

Mesure of height

Selection of children with height < 2SD (2500)

Acceptance. Inclusion refusal

Exclusion POCT

PositiveNegative

Suspicion of IgA deficiency

Determination of IgA

Confirmation No IgA deficency

IgG anti endomysium

PositiveNegative

ELISAEndoscopy

Steps planned• May-June 2014: get the final approval from the Ministry of

Health, Department of School Medicine and Ethics Committee • September 2014: training meeting for school doctors • September-November 2014: obtaining and filing the

anthropometric measurements of children (only height?)• December 2013: sending mail for parental consent for the

selected population (Height <-2SD, n=2500). • January 2015: POCT for all and samples for ELISA for positive or

IgA deficiency children• February and March 2015: endoscopy for positives • April 2015: analysis of results

Estimated budget• POCT: 7500 euro • Training (meeting): 3000- euro• equipment to measure the size? • Secretariat (Secretary contract, mail ...): 3000 euro • Displacement: 4000 euro • other: 3000 euro • “Gift for schooldoctors”!!: 5000 euro? • Total: 25500 euro• Budget available for study in 2014: 14000 Euro

expected difficulties

• Mostly administrative: Net decrease in administrative efficiency since the revolution (extreme slow, iterative change managers ...) for example, we introduced three times the project at the Ministry!!

• enthusiasm school doctors! • need to expand the team of the research unit

(now, only me and Nadia Siala!!)