Jean-Louis Lanoë Social sciences coordinator

Jean-Louis LanoëSocial sciences coordinator

Elfe

A French Birth Cohort Study

ELFE” is an acronym for “Étude Longitudinale Française depuis l’Enfance” (French Longitudinal Study since Childhood)

The core methodology of the project is : enrolment and long-term follow-up of a nationally representative cohort of 20,000 children born in 2011

National Partnership

INSTITUT DE VEILLE SANITAIRE

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The scientific objectives and methods of Elfe

The pilot surveys

Education, socialisation and family in the project

- the 'socialisation-education‘ focus group

- the 'school’ focus group

In this communication we present and discuss :

The objectives of the project cover the fields of Social Sciences, Public Health and Environmental Health

Main line: Child Development

Situation at birth (perinatal data) and future health (behavior, nutrition, diseases, accidents…)

Context and interactions: familial, social, economic, physical environment

Physical and cognitive development of the child, educational course, access to work

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Main topics

Social Sciences

• Demographics• Socialization-

Education• Economy-

precariousness

Health- environment

• Chemical exposure• Physical exposure• Environmental

contamination

Cross-disciplinary themes

• Perinatal period • Growth

• Respiratory diseases

• Nutrition

• Psychomotor development • Cancer

Health

• Accidents & trauma• Use of health-care• Infectious diseases

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• School

Methodological aspects (1)

A nationally representative sample of children (births)

All children born in France on 6 specific days of 2011 (April, June, September and December)

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The sample of children to be included in the Elfe cohort :

A two stage random stratified plan with a comprehensive drawing in the second stage.

- first : selection of a stratified sample of maternities (primary units),

- second : inclusion of all births (secondary units) occurring the predetermined days of the survey.


542 maternities identified in metropolitan France (after updating for mergers, deletions or creations in the last list available -2008 -).

Sample design was set in order to investigate around 40 500 births :

- an estimated participation of maternities of 90 % and

- 55% of mothers accepting their children to be included in the cohort 20 000 children in the cohort


The 542 maternities were classified in 5 strata of equal size (quintiles), constructed on the number of births occurring in the year 2008.

Within each stratum the maternities were sort by :

- region (5 large regions),

- technical level of the maternity (3 levels)

- legal status (2 status).


A variable proportion of maternities (100% of the

largest , 25 % of the smallest) was drawn in each stratum (implicit stratification)

total number of births in the sample equals 40 400,

- 342 out 542 maternities were drawn (63%)

- the rate between extreme initial weights is 4.15.


Data Collection Plan at different ages (1)

14 ²²² 20 years

6 years

5 years(el. sch.)

3 years

2 years1 year

8 weeks

Birth

Pregnancy

Interview + med files, midwivesBiological samples, midwives

Tel Interview

Tel Interview + m.d questionnaires

Face-to-face Interview +m.d questionnaires

Tel. Interview

Tel interview + school evaluation

Passive longitudinal follow-up from:

School follow-up,DEP, Ministry of education (5 y+)

Environmental data/GIS (InVS)

Medical Data (use of data from Medical System: SNIIRAM)

Insee Demographic Panel (EDP)

Face to face Interview Phys exam+ Psych.tests, Blood Sample (nurse)

At birth in the maternity :

- a 20’ questionnaire + information from medical files

- Biological samples (maternal urines, milk, blood, hair and cord blood)

2 months after birth :

- Phone interview (1hour)

- Daily records on nutrition

- Environmental sensors (dust)

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sData Collection Plan at different ages (2)

Others steps :- Phone interviews at 1 year, 2 years (with records from

physician interview)

- Face to face interview at home at 3 years with biological samples of the child (urines) and environmental sensors (dust)

- Phone interviews at 5 years

- Medical examination at 6 years

Access to other sources :- Those of the Demographic panel (Census data, vital statistics)- Geo-matching with external data on air pollution, quality of water- Family Allowances - Social security system (RNIIAM, PMSI)- Data on children living outside their family (institutions, other families)

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Data Collection Plan at different ages (3)

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Pilots studies

Test acceptability, feasibility and relevance of the national survey

Two waves : children born in all maternities of : Bourgogne and Picardie on 2, 3 and 4 April 2007 and Isère, Loire, Savoie, Ardèche et Seine-Saint-Denis les 1, 2, 3 et 4 october 2007

74 maternity units surveyed : 900 expected births

Tracking in the pilot survey (1)

In the maternity unit- 915 births but 834 with inclusion criteria

- 447 women accepted the study and have correct adress

- Sucess rate = 54%

Causes of failure- 50% refusal (10% from the father)

- 22% due to language difficulties

- 12% due to failure to make contact (mother leaves maternity unit)

- 9% due to child health status

- 3% due to mother health status

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Biological samples collection (pilot)


At 2 months : interview (home face to face interview)

- 447 with corrected adress sent to Insee

- 384 women were interviewed (and 352 fathers)

- Attrition = 6,9%

- 86% mothers and 79% fathers accepted

- 7% mothers and 11% fathers refused- 5% of mothers and 6% of fathers could not be contacted

by phone

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At 1 year

- 419 with corrected adress sent to pollster

- 343 women were interviewed- Attrition = 6,7 %

At 2 years

- 390 with corrected adress sent to pollster

- 318 women were interviewed

- Attrition = 7 %

- 3 years survey is ongoing

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Education, socialisation and family in the project (1)

The focus group ‘Socialization-education’ main topics :

Family relations : rites, relation parent-child

Division of domestic labor

Worldview of parents : religion, politics, justice, relationship to the social environment, perception of social order, religious education

Caring for the child : childcare for children, school- family relationship

Learning : the first links, educational practices motor development, language, behavior, motor fonction, child learning

Children’s corner : fun activities, relationship to the body


The focus group ‘Socialization-education’ : Forthcoming projects

- Juvenile delinquency in college : long-term project (social morality, embedding socio geographic determinants)

- The accommodation of the child during her first year: short-term project

- The child and his family: short-term project (siblings and extended family in the context of blended families)

- Separation of parents and economic well-being of children: medium and long term projects:

- Child and family, family relationships over time : long-term project


The focus group ‘Socialization-education’ : Forthcoming projects

-Living conditions, family practices and school achievement in CP: medium-term project (integrate childcare and cultural practices)

- Production of identities and gender inequality

- Working mothers and family arrangements (work, income, childcare, marital)


The focus group ‘School’ :

- responsible for the construction of protocols on the course and school performance in link or not with the Ministry of Education.

- A mixed group "Education-socialization" and "development".

- Investigation and evaluation might be done in the year 2016-2017 by the Department of Education on the older Children in Kindergarten

- problem would be to find the ‘Elfe children’ among those who would be evaluated (20 000 /800 000) + limited choice concerning the types of questionnaires

-


The focus group ‘School’ :

- If no evaluation by the department of education : need to identify schools where children are educate

- Tests would be passed in two sequences of 20 minutes each to cover areas such as :

- the mastery of language (oral, written)

- numerical skills

- reasoning, cognitive activities

- fine motor skills, physical activities

- school behavior, school readiness, ability to learn (questionnaire for teachers)

Jean-Louis Lanoë

Thank you for your attention

Gracias por su atención

Legal issues in France (1)

• The collection of a large amount of data on the same individual requires a strict policy for protecting the privacy of these data

• Each set of data will be stored separately, with a specific identifier

• All databases will be strictly anonymous. A third party will keep the links between the name of a participant and his identifiers in the data files. The data files and the identification file will be kept by separate institutions

• Access to data will be authorized by a special Committee, and under conditions preventing all possibilities of ‘indirect identification’

• The technical conditions of this access are not yet decided (local or distant access to a unique server...)

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Legal issues in France (2)

• Specific to Elfe controls: The Scientific Committee and The Group on ethics

• National controls:

- CNIS (National Council for Statistical Information)

- CNIL (National Data Protection Authority)

- CCTIRS (National Committee for the Treatment of Data in Research on Health)

- CPP (Local Committee for the protection of individuals in case of biological samples)

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Nathalia Baltzinger

Cohort maintenance on the pilot study

Cohort maintenance

Main objectives

Tested strategy

First results

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Main objectives

Minimise sample attrition due to failure to locate families

Encourage members to stay in the cohort

To reach these objectives, the ideas were :

- to keep in touch with the families in-between waves

- to be quartely (or four times a year) present

- to commit the members by giving them information about the study

- but to avoid being too intrusive

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Strategy tested on the pilot (1)

A cohort maintenance’s strategy mainly based on :

Informative documents

Greeting card policy

Gift policy

Email surveys

Pilot family group

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Informative documents (1/4)• Printed documents

• Leaflet• This document is given at the

hospital at the end of the first interview

• It shortly presents the study (main objectives, schedule, etc.)

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Informative documents (2/4)

• Printed documents

• Elfe Infos• A newsletter sent home twice a

year• Its purposes :

• explaining the study• presenting the major

results• reminding the families

of the next interviews37


Informative documents (3/4)

• Printed documents

• Mails or letters announcing interviews

Before each wave, a letter is sent

home with the major details of the interview

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Strategy tested on the pilot (5)Informative documents (4/4)

What about our web policy ?

For the pilot study : a rather « shy » web policy• December 2009 : 65 % of french people were

Internet users

For the national study : a specific web policy • In the next few years we will develop an internet

policy with specific messages and blogs

- for the families

- for the children (when they will be able to use Internet)

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Greeting card policy (1/3)

• Birthday cards

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• New year’s cards (printed and electronic)

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• Postage-paid cards for families to give us their new address

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Gift policy• As most studies in France, Elfe is a non-paid study.

No financial incentive can be given.• Our purpose was just to give families something to

thank them for their participation• Our problem was to find something :

• related to study• neutral• useful• nice looking• not bad for the children’s health• lasting

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Gift policy

What we tested on the pilot cohort :• 2 months survey : a magnet branded with our

study’s logo• 1 year survey : an embroidered bib• 2 year survey : a pop up flap book• 3 year survey : a smaller cheaper book

What is planned for the national cohort :• Giving the baby a small organic cotton blanket

which hopfully will become his or her « blankie »

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@mail survey• check the adresses (e-mail and mail)• check the families’ understanding of Elfe• check their opinion on our methodology• engage the respondent sufficiently so that he

or she wants to stay in our cohort

Main results• 167 mothers ad 130 fathers received the

survey • 78 mothers and 36 fathers answered• 74 % (mothers and fathers) declared that they

had not understood Elfe's objectives45


Pilot family group

• check their opinion on :• our methodology• our questions• our communication policy

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First results

It turned out that :

families don’t like to be too « sought after »

two thirds of the families who quit the study said it was because the survey was too much « time consuming »

the postage-paid card was returned by only 11 families (VS 391 sent)

families really appreciated our gifts, the greeting cards and the newsletter we sent them

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Conclusion and questions

This policy will help us for the cohort maintenance and the creation of a membership feeling

Some events or actions we did not test (meetings, blog or Internet forum, etc) will certainly be useful

We are very interested in your ideas and suggestions, so please feel free to share them with us

Is it possible to get in touch with people in charge of communication in your study ?

If you have any questions, Stéphanie and I will be pleased to answer them.

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La collecte biologique dans ELFE – Etude nationale

Présentation EFS – 02/04/2010 Page 49

Concerne:• 10 000 couples mère-enfant(s)

• Certaines maternités Taille +++ : > 500 naissances/an

Proximité géographique centre EFS (partenariat)

Se déroule:• En 2 étapes:

Accouchement (J0)

En suite de couche (J1-J3)

Organisation générale de la collecte nationale

Page 50Présentation EFS – 02/04/2010

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Some questions to answer…

In the field of Health • What are the exposure levels to physical (noise…),

chemical (tobacco smoke, pesticides…) and biological (allergens…) factors during pregnancy and early childhood and what are their long term consequences?

• What are the early origins of obesity?

In the field of Social Sciences• What are the effects of Poverty and Social Policies on

families and children?• What are the consequences of Family composition

(blended families, single parent families…), events (divorces and second marriages…) and constraints (employment of the mother, long distance commuting…) on children development and life?

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…

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Jean-Louis Lanoë, 1 des 4 coordinateurs scientifiques du projet Elfe

- Deux médecins, chacun à mi temps, se partagent la coordination scientifique du domaine santé :

• Corinne Bois, médecin de PMI dans les Hauts de Seine, et

• Marie Noëlle Dufourg, pédiatre, à l’hôpital Antoine Béclère à Clamart.

- Ilias Kavouras, spécialiste de la chimie de l’environnement nous à rejoint il y a un peu plus de 6 mois depuis l’université de la Vegas. Coordination du domaine ‘environnement’ ; il remplace Stéphanie Van Dentorren, rappelée à l’Institut de Veille Sanitaire

…

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Enfin moi même, économiste, chercheur à l’Inserm

- Intégration dans l’équipe il y a maintenant presque deux ans

- coordination sciences sociales du projet après Claudine Pirus.

…

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Le travail de coordination scientifique dans le projet Elfe.

-faire émerger des programmes de recherche cohérents sur les diverses thématiques propres à chaque domaine.

- nécessité en amont d’une large concertation avec les équipes de recherche

- négociations et des arbitrages ‘intra thèmes’ et ‘inter domaines’ sur la place des uns et des autres

Une tâche pas toujours facile !!

à permettre que les programmes de recherche puissent trouver concrètement la ‘substance’ dont ils ont besoin, donc :

- que les enquêtes soient possibles,

- qu’elles se réalisent dans de bonnes conditions et

- que les données collectées soient de qualité.

En ces matières ce sont les services de l’Ined qui jouent un rôle majeur par leur expertise et leur compétence.

Le travail de coordination scientifique consiste aussi

- service des enquêtes pour tout ce qui concerne la finalisation des questionnaires et les relations avec les prestataires à l’occasion des enquêtes pilotes,

- service de méthodologie statistique (échantillonnage, pondérations),

- service juridique pour tout ce qui relève des appels d’offres à prestataires et de la constitution des dossiers pour la CNIL, Le CCTIRS

- service des ressources humaines pour principalement pour les embauches liées au projet.

Documents

Jean-Louis Lanoë Social sciences coordinator