ESBIO Workpackage 2: Deliverables and status quo

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ESBIO Workpackage 2Deliverables and status quo

• M. Kolossa-Gehring,
• N. Kirsch,
• M. Seiwert
• and
• K. Becker
• Luxembourg, 28 Nov. 2006

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Deliverable 2.3.1
Proposal for population sampling, recruitment
and biological sampling Prepared by Nils
Kirsch
Work commenced after IG reached a decision on
essential elements in the course of the 3rd
Recommendations
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Population Sampling

• Study Population children (6-11 yrs) and
  their related mothers (22-50 yrs)
• Eligible - same household, resident ? 3 yrs
  - language
  competence - non-smoking (??? next slide)
• Pre-Selection of..
• Locations either ? representative pattern,
  NUTS, etc or ? trifocal
  urban/rural/industrial
• Participants either ? official register/tel.
  directory or ? school/health
  authority/MD

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Cotinine in childrens urine (µg/l)and smoking
status of mothers
Note children 6 11 years of age from GerES IV
2003/06 P25 P99 percentiles
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Number of Samples

• fixed rate vs. fixed numbers
• Rate based on children population (group 6-11
  yrs) ? Problem greatly varying MS populations
  (next slide) setting of upper and lower limits
  likely ? two-sided distorted rate ? useful??
• Fixed Numbers according to project objectives
  ?Feasibility 2 x 25 50
  samples/MS ?Research 2 x 120 240
  samples/MS ? MS have a choice but less
  room for downsizing negotiations

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Examples for Sampling Rates
Notes not ALL EU-countries extracted data
as of 1 Jan 2004 Time 1 Jan 2005 ( 1 Jan
2004) Date of extraction Mon, 20 Nov. 06
125545
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Recruitment

• Three-step approach -- several options
• 1. Step addressing the pre-selected mothers by
  means of written information.
• Directly ? via registry office/health care
  system/ paediatrist/GP
• Indirectly ? by the child via school/day care
• Aim sensitisation, postal reply with contact
  data
• Options in/exclusion questionnaire
  telephone

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• 2. Step establishing contact and gaining
  (intended) participation
• contact person, telephone hotline, website, add.
  info regarding data privacy, ethics, result
  reporting, etc
• eligibility and non-responder evaluation
• Options ? mail, telephone, field worker
  visit ? separate info/invitation suitable
  for children ? policy on
  non-response/over-sampling ? policy on
  participants individual convenience and
  favoured dates

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• 3. Step obtaining written consent to
  participate by acknowledgement of.
• general comprehension of study and conduction
• rules of data protection and use of data
• collection of specified specimen
• potential storage and anonymous re-analysis
• right and mode to withdraw consent
• possibility to obtain a personal report
• contact in case of follow-up/new programme
• Options additional consent of child/father

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Biological sampling

• Morning urine
• self-dependent at home, following instructions,
  brief log
• suitable 1-L vessel to be provided
• storage under refrigeration max. 15 hrs
• delivery to specified Health/Examination Centre
• partition into small volumes (6-15 ml)
• documentation and labelling
• deep freezing for transport to lab and storage
• Option pickup service from participants home

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• Whole blood
• medical staff and appropriate facility required
• transparent and sensitive explanation prior to
  sampling
• explicit consent needed best care and attention
  concerning children
• EMLA plaster recommendable for children
• VACUTAINER for withdrawal of few ml
• partition in suitable vial/container if necessary
• documentation and labelling
• instant deep freezing for transport to lab and
  storage

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• Scalp hair
• trained staff and special scissors required
• needed equipment can be portable/mobile
• explicit consent
• cutting at back of the head and close to scalp
• small amount (100-200 mg) sufficient
• storage in suitable bag/container, no
  preservation
• documentation and labelling
• Option sampling location can be assigned
  according to convenience

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Deliverable 2.4

• Proposal for a harmonised way of collection,
• analysis and data management
• Prepared by Margarete Seiwert

Work in progress, presentation lays
focus on data management
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Protection of privacy
Personal data (stored separately, access by data
protection officer)
Anonymous data (for evaluation)
Questionnaires
private data (e.g. name, address)
private data (e.g. name, address)
ID-number
ID-number
ID-number
ID-number
ID-number
ID-number
ID-number
ID-number
ID-number
ID-number
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Evaluation of recruitment
MS Arecommendations for improved recruitment
Central Unitcompilation and communication of
recommended measures
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Evaluation of compliance
MS Arecommendations for improved compliance
Central Unitcompilation and communication of
recommended measures
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How to handle extreme values?
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Quality Control of analytical measurements
not acceptable MS lab data cant be used
systematic error
perfect
correction by regression analysis?
reanalysis by Ref. Lab?
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Example Description of individual pollutant
concentrations
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Example Description of Exposure
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Procedure for reporting individual results
Generating report
Data bases
Sending report
Measurement data(Pb-B, Hg-H, Cd-U, Cot-U)
Private data (e.g. name, address)
evaluation of individual pollutant
concentrations
Questionnaire data(e.g. smoking, fish
consumption)
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Thank your for your attention!