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Chiari Malformation Project Database CM1 D

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Projet Online Database of rare illnesses
Chiari Malformation I and Syringomyelia.
For collaboration visit to http://www.aismac.org/statistiche_000.php
or email: aismac@alice.it

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Chiari Malformation Project Database CM1 D

  1. 1. Orfeo Mazzella | CM1D database 1
  2. 2. Introduction The involvement of the patient on the part of the scientific community and the of voluntary associations in the collection and sharing of online data is as follows: – for the promotion of health and for the study of it’s natural evolution – Quality of Life – for the improvement of auditing “ clinical risk” – for the distribution and common usage of scientific knowledge – to supply a scientific base for the comprehension and the study of health – to establish a universal language to describe health and it’s conditions in order to improve communication between diverse users: medical staff, researchers, political exponents and the population – to render possible a comparison between data collection worldwide – to supply a systematic coding scheme for in house healthcare IT systems Orfeo Mazzella | CM1D database 2
  3. 3. The collection of data adheres to all privacy norms www.garanteprivacy.it/garante/navig/jsp/index.jsp Orfeo Mazzella | CM1D database 3
  4. 4. Data according to SISMEC and CEAS recommendations Recommendations of good practice in the research of epidemiology and clinical environment www.sismec.info Orfeo Mazzella | CM1D database 4
  5. 5. Recommendations The publication of means of mass media must come about only after the results have been revealed in an appropriate scientific contest and, possibly, through divulging the source (According to clinical environment - SISMEC) Orfeo Mazzella | CM1D database 5
  6. 6. The collection of patient data: Quality of life Orfeo Mazzella | CM1D database 6
  7. 7. The collection of data adheres to the principles GPC (Guideline for Good Clinical Practice) Principals of ethics of the Helsinky declaration Orfeo Mazzella | CM1D database 7
  8. 8. Data sharing The sharing and availability of data allows to “audit” thus allowing a guarantee that the patient receives the best possible treatment clinical practice improvement the work to improve generally an optimal supply of resources this service becomes an opportunity for training and up - to - date research Orfeo Mazzella | CM1D database 8 8
  9. 9. Why collect the data? The systematic compilation of data and of information is a fundamental element in healthcare. The world of healthcare is in charge of organizing this data in a systematic and trustworthy fashion, so that a decision maker put in such a situation of having to look at all relevant material available can readily use the necessary data at hand The same goes for the patient end – user who is also guaranteed a more trusting rapport with his doctor if the data can be efficiently found at hand Orfeo Mazzella | CM1D database 9
  10. 10. Registry, archive or database? Orfeo Mazzella | CM1D database 10
  11. 11. Definition of a database • A database, or data bank, is a structured collection of records or filing system that is stored in a computer system. The structure is achieved by organizing the data according to a database model. It can be accessed (for data inputting, research, management and data maintenance) via system software • The database is a gathering of information, of data which is then subdivided into a logic order into tables to be then split up into fields Orfeo Mazzella | CM1D database 11
  12. 12. Definition of data source 1.51 Source Data All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for it’s reconstruction and evaluation. Source data are contained in source documents (original records or certified copies) European Medicines Agency July 2002 Guideline for Good Clinical Practice Orfeo Mazzella | CM1D database 12
  13. 13. Definition of document source 1.52 Documents Source • Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x- rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial). European Medicines Agency July 2002 Guideline for Good Clinical Practice Orfeo Mazzella | CM1D database 13
  14. 14. Generic database for rare illnesses on internet •NORD (National Organization Rare Disorders) •ORDR (Office Rare Disease Research) •SRDD (Swedish Rare Disease Database) ORPHANET •CNMR (Centro Nazionale Malattie Rare) Orfeo Mazzella | CM1D database 14
  15. 15. NORD www.rarediseases.org Orfeo Mazzella | CM1D database 15
  16. 16. ORDR www.rarediseases.info.nih.gov Orfeo Mazzella | CM1D database 16 16
  17. 17. SRDD www.socialstyrelsen.se/en/rarediseases Orfeo Mazzella | CM1D database 17
  18. 18. ORPHANET www.orpha.net Orfeo Mazzella | CM1D database 18
  19. 19. CNMR www.iss.it/cnmr Orfeo Mazzella | CM1D database 19
  20. 20. Specific database for rare illnesses on internet • ORCID (Orthopaedic Rare Conditions Internet database) • RBDD (Rare Bleeding Disorder Database) • GDMCC (Genetic Disorder Mucociliary Consortium) • EN-RBD (European Network Rare Bleeding Database) • ESID (European Society for Immunodeficiensies Database) • CM1D (Chiari Malformation 1 Database) Orfeo Mazzella | CM1D database 20
  21. 21. ORCID Orthopaedic Rare Conditions Database Orfeo Mazzella | CM1D database 21
  22. 22. RBDD Rare Bleeding Disorder Database Orfeo Mazzella | CM1D database 22
  23. 23. EN-RBD European Network Rare Bleeding Database Orfeo Mazzella | CM1D database 23
  24. 24. ESID European Society for Immunodeficiencies Orfeo Mazzella | CM1D database 24
  25. 25. CM1D Chiari Malformation 1 Database http://aismac.unior.it Orfeo Mazzella | CM1D database 25
  26. 26. What is the database used for? – Mainly to observe the natural history of pathologies – For observational studies – To promote the knowledge and sharing new discoveries on MC1 e SM – To reunite distributed data with countries out of reach Orfeo Mazzella | CM1D database 26
  27. 27. What info to is required? – Info related to the quality of life – Info from the patient records according to the present consensus – The patient’s outcome Orfeo Mazzella | CM1D database 27
  28. 28. Is the data input anonymous? – Yes, it is anonymous and scrambled anonymous user Orfeo Mazzella | CM1D database 28
  29. 29. Who inserts the data? – The doctors – The patients Onto the records of the health care centre Orfeo Mazzella | CM1D database 29
  30. 30. Is the data constantly updated? – Yes, on the basis of a yearly follow- up Orfeo Mazzella | CM1D database 30
  31. 31. How is the data collected? – Via a programme on a remote Italian server Orfeo Mazzella | CM1D database 31
  32. 32. Where is the server that hosts the database? Orfeo Mazzella | CM1D database 32
  33. 33. Do you need to install a program on the PC to access? Orfeo Mazzella | CM1D database 33
  34. 34. Is it possible to share the found data on a network? – Yes, it is – You can do this simultaneously between multiple users Orfeo Mazzella | CM1D database 34
  35. 35. From where is the data accessible? – Wherever you are – Anywhere in the world via the internet connecting you to the project page Orfeo Mazzella | CM1D database 35
  36. 36. Are there any otherways of accessing the data? – Yes, every user has his own personal password for access Orfeo Mazzella | CM1D database 36
  37. 37. Is there a way of controlling the data’s safety against fraud? – Yes, for example you cannot duplicate any data entered Orfeo Mazzella | CM1D database 37
  38. 38. Is it possible to add X rays to the database? – Yes, in addition to the DICOM data the X ray would automatically be erased afterwards ensuring privacy by using a program especially for this purpose Orfeo Mazzella | CM1D database 38
  39. 39. Is the information of the patient’s privacy safe? – Yes, the patient is identified in the database through a number generated at random Orfeo Mazzella | CM1D database 39
  40. 40. How do you surf the database? – Through some cards linked to eachother Orfeo Mazzella | CM1D database 40
  41. 41. Who owns the data? – The patients who have authorised this in written format (art.26 D.lgs 196/2003) – An authorised person is named who guarantees safety of the data (art. 28 D.lgs 196/2003) Orfeo Mazzella | CM1D database 41
  42. 42. Can the data be used to carry out a study? – Yes, in an anonymous way Orfeo Mazzella | CM1D database 42
  43. 43. http://aismac.unior.it Orfeo Mazzella | CM1D database 43
  44. 44. CM1D Chiari Malformation 1 Datebase Orfeo Mazzella | CM1D database 44
  45. 45. CM1D Chiari Malformation 1 Datebase Orfeo Mazzella | CM1D database 45
  46. 46. CM1D Chiari Malformation 1 Datebase http://aismac.unior.it/Adesione.php?IdLingua=2 Orfeo Mazzella | CM1D database 46
  47. 47. CM1D Chiari Malformation 1 Datebase Orfeo Mazzella | CM1D database 47
  48. 48. CM1D Chiari Malformation 1 Datebase Orfeo Mazzella | CM1D database 48
  49. 49. CM1D Chiari Malformation 1 Datebase Orfeo Mazzella | CM1D database 49
  50. 50. CM1D Chiari Malformation 1 Datebase Orfeo Mazzella | CM1D database 50
  51. 51. CM1D Chiari Malformation 1 Datebase Orfeo Mazzella | CM1D database 51
  52. 52. CM1D Chiari Malformation 1 Datebase Orfeo Mazzella | CM1D database 52
  53. 53. CM1D Chiari Malformation 1 Datebase Orfeo Mazzella | CM1D database 53
  54. 54. CM1D Chiari Malformation 1 Datebase Orfeo Mazzella | CM1D database 54
  55. 55. Partnership Orfeo Mazzella | CM1D database 55
  56. 56. Thank you for your kind attention Orfeo Mazzella | CM1D database 56
  57. 57. http://aismac.unior.it aismac@alice.it Orfeo Mazzella | CM1D database 57

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