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Approaches to the definition of common data elements
- 1. Approaches to the definition of common data elements EPIRARE Rare Disease and Orphan Drug Registries EPIRARE International workshop October 8-9, 2012 Italian National Institute of Health Rome (Italy)
- 2. The French Minimum Data Set for Rare Diseases : a 3-step method P. Landais, A. de Carrara, C. Messiaen, M. Macabiau, JP. Necker, A. Priouzeau and R. Choquet and the 131 French reference centers for rare diseases Supported by the French ministry of Health
- 4. Axis A Improve the quality of patient ’s care A1- Improve the access to diagnosis et care A-1- 4 Coordinate the «rare diseases» structures with a shared information system
- 5. Axis B DEVELOP RESEARCH ON RD B-1 Create a national structure to impulse rechesearch with public and private partners B-1-1 Create a foundation dedicated to rare diseases
- 6. Two complementary programs RaDiCo Research BaMaRa Public health Minimum data set All patients Groups 1 Cohorts (Phenomics) Subgroups of patients CRMR1 CRMR2 CRMR3 t0 t1 t2 t3 t4 CRMR4 CRMR5 2 CRMR6 CRMR7 t0 t1 t2 t3 t4 t5 t6 CRMR8 3 CRMR9 t0 CRMR10 …. t1 t3 t4 t6 t5 CRMRn CRMRn+1 t0 CRMR128 18 t2 t1 t2 t3 t4 t5 CRMR129 CRMR130 CRMR131 t0 t1 t2 t3 t4 t5 t6
- 7. A joint information system for BaMaRa and RaDiCo Program BaMaRa RaDiCo Grand emprunt Context Ministry Ministry of Health Gestion DGOS -> APHP Objective Public Health Governance Paul Landais Budget 0,5M€/y/5 years Ministère of Research Inserm -> Foundation RD Research S.Amselem A.Clement P.Landais 0,95M€/y/10 years Shared gestion Shared gestion Shared resources Joint Information System Joint Information System ISy-rare
- 8. Building the RD Minimum data set: a 3 step approach Svensson-Ranallo PA, Adam TJ & Sainfort F AMIA Summits Transl Sci Proc 2011;2011:54-8
- 9. step 1 : collecting the existing material MDS working group Existing MDS Scientific Literature 131 centers of reference
- 10. Step 1 : needs gathered from the French centers of reference Orphan drugs Anthropometric data Imaging Clinic Biology Diagnostic Anatomo-pathologic Administrative Other Biological sample Clinical trial participation Genetic Evolution data Epidemiologic Socioeconomical Reproduction history Family history
- 11. step 2: filtering MDS 0.1 BNDMR ministry office working group Survey 1 MDS working group Survey 1 131 centers of reference
- 12. step 3: content definition and standardization BNDMR ministry office working group Survey 2 MDS working group Survey 2 131 centers of reference Standards : HL7, SNOMED, Orphanet, OMIM, HPO, SNOMED
- 13. 9 groups of items were retained Patient identification Treatment Structure of the care unit Activity Contextual information Ante and neonatal information Diagnosis Consent Research samples
- 14. Standards of coding Standardisation : the use of standards to discard artifacts (data elements, or information models) and qualify content (coding item) Standards for information models/data elements: SNOMED (3.5, CT) HL7 openEHR (EN 13606) Terminologies: Clinical Terms : LOINC, SNOMED CT Orphan drugs : RxNorm, ATC, Theriaque, Vidal, Orphanet Diagnostic MR : Orphanet Signs : HPO (CIM10, signs to be validated) Genes : OMIM, GenATLAS, Ensembl