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Jean-Louis Lanoë Social sciences coordinator

Elfe A French Birth Cohort Study. Jean-Louis Lanoë Social sciences coordinator. ELFE” is an acronym for “Étude Longitudinale Française depuis l’Enfance” (French Longitudinal Study since Childhood)

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Jean-Louis Lanoë Social sciences coordinator

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  1. Elfe A French Birth Cohort Study Jean-Louis Lanoë Social sciences coordinator

  2. 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

  3. INSTITUT DE VEILLE SANITAIRE National Partnership

  4. In this communication we present and discuss : 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 4

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

  6. 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 6

  7. Cross-disciplinary themes Main topics Social Sciences • Demographics • Socialization-Education • Economy-precariousness Health- environment • Chemical exposure • Physical exposure • Environmental contamination Health • Accidents & trauma • Use of health-care • Infectious diseases • Psychomotor development • Cancer • Respiratorydiseases • School • Nutrition • Growth • Perinatal period 7

  8. 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) 8

  9. Methodological aspects (2) 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.

  10. Methodological aspects (3) 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

  11. Methodological aspects (4) 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).

  12. Methodological aspects (5) 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.

  13. Data Collection Plan at different ages (1) Passive longitudinal follow-up from: Face to face Interview Phys exam+ Psych.tests, Blood Sample (nurse) 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) 14 ²²² 20 years 6 years 5 years(el. sch.) 3 years 2 years 1 year 8 weeks Birth Pregnancy Tel interview + school evaluation Face-to-face Interview +m.d questionnaires Tel. Interview Tel Interview + m.d questionnaires Tel Interview Interview + med files, midwives Biologicalsamples,midwives

  14. sData Collection Plan at different ages (2) 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) 14

  15. Data Collection Plan at different ages (3) • 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) 15

  16. Pilots studies Test acceptability, feasibility and relevance of the national surveyTwo 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

  17. 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 17

  18. Biological samples collection (pilot)

  19. Tracking in the pilot survey (2) 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 19

  20. Tracking in the pilot survey (3) 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 20

  21. 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

  22. Education, socialisation and family in the project (2) 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

  23. Education, socialisation and family in the project (3) 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)

  24. Education, socialisation and family in the project (4) 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

  25. Education, socialisation and family in the project (4) 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)

  26. Thank you for your attention Gracias por su atención Jean-Louis Lanoë

  27. 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...) 30

  28. 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) 31

  29. Cohort maintenance on the pilot study Nathalia Baltzinger

  30. Cohort maintenance Main objectives Tested strategy First results 33

  31. 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 34

  32. 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 35

  33. Strategy tested on the pilot (2) 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.) 36

  34. Strategy tested on the pilot (3) 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 interviews 37

  35. Strategy tested on the pilot (4) 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 38

  36. 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) 39

  37. Strategy tested on the pilot (6) Greeting card policy (1/3) • Birthday cards 40

  38. Strategy tested on the pilot (7) Greeting card policy (2/3) • New year’s cards (printed and electronic) 41

  39. Strategy tested on the pilot (8) Greeting card policy (3/3) • Postage-paid cards for families to give us their new address 42

  40. Strategy tested on the pilot (9) 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 43

  41. Strategy tested on the pilot (10) 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 » 44

  42. Strategy tested on the pilot (11) @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 objectives 45

  43. Strategy tested on the pilot (11) Pilot family group • check their opinion on : • our methodology • our questions • our communication policy 46

  44. 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 47

  45. 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. 48

  46. La collecte biologique dans ELFE – Etude nationale 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) Présentation EFS – 02/04/2010 Page 49

  47. Organisation générale de la collecte nationale TRANSPORT 4°C SANG VEINEUX URINES Sage-femme bloc SANG DU CORDON MORCEAUX DU CORDON* TRAITEMENT, DOSAGE et STOCKAGE CHEVEUX DE LA MERE LAIT MATERNEL STOCKAGE 4°C Sage-femme enquêtrice Mère MECONIUM* ANALYSE par les chercheurs *OPTIONNEL Présentation EFS – 02/04/2010 Page 50

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