Romanian experience:regionalization, guidelines,  National RDS Registry              Maria Livia Ognean                Sib...
Romanian modern Neonatology• 1994 – residency in Neonatology• 1993 – 2005 - Newstart I, II, III:   • Humana Foundation   •...
Romanian modern Neonatology• 1996   • Romanian Association of Neonatology   • Neonatologia – the journal of the Romanian A...
Romanian modern Neonatology• 2000 - RoNeoNat – Romanian Swiss Program:   • Neonatology training workshops   • Quality mana...
Romanian Regionalization of the Perinatal Care• 2002 – Government Decision 534/30.05.2002 regarding the  strategy for reha...
Romanian Regionalization of the Perinatal Care2006 - Public Health Ministry:• Order 1778/28.12.2006: regarding the norms f...
Romanian Regionalization of the Perinatal CareFrom 2006:• Step-by-step implementation of the regionalization• Main obstacl...
Next step: Neonatology Clinical Guidelines• National Neonatology Guidelines   • Romanian Association of Neonatology   • Up...
National Neonatology Clinical Guidelines• Reasons & Aims:   • Reducing neonatal morbidity & mortality   • Natural continua...
National Neonatology Clinical Guidelines• Working Groups:  • Coordinating Group  • Technical Groups for each guideline:   ...
National Neonatology Clinical Guidelines• SIGN methodology for the guidelines development• AGREE instrument for the review...
Methodology for the guidelines development:                              Subject selection                        Working ...
National Neonatology Clinical Guidelines•    SIGN methodology for the guidelines development:     • What (how), who, when?...
National Neonatology Clinical Guidelines•     SIGN methodology for the guidelines development:      • What (how), who, whe...
National Neonatology Clinical Guidelines•   SIGN methodology for the guidelines development:    • What (how), who, when?  ...
National Neonatology Clinical Guidelines• Health Ministry Order 1232/02.08.2011 regarding the  approval of Medical Practic...
National Neonatology Clinical Guidelines• Guidelines in progress:  • Volume 2:      –   Parenteral nutrition of the preter...
Next step: National Registry for RDS• 2010: Romanian Association of Neonatology   • Support from Chiesi Romania   •   Conc...
Romanian National Registry for RDS         The International Neonatology Conference, Kyiv 2013
Romanian National Registry for RDSAims:• Improvement of the medical care for neonates and their  families   • Quality & sa...
Romanian National Registry for RDSOpportunities:• Cross-institutional collaboration• Benchmarking (search for the best pra...
Romanian National Registry for RDSDatabase conceived to:• Document performances• Compare strategies• Compare outcomes• Ide...
Romanian National Registry for RDSDatabase:• Epidemiological data• Management/care, focused on:   • Birth resuscitation   ...
Romanian National Registry for RDSDatabase - structured to provide realiable and confidential data  for the:• Quality mana...
Romanian National Registry for RDS         The International Neonatology Conference, Kyiv 2013
Romanian National Registry for RDS         The International Neonatology Conference, Kyiv 2013
Romanian National Registry for RDS         The International Neonatology Conference, Kyiv 2013
Romanian National Registry for RDS      epidemiological data                                                        antena...
Romanian National Registry for RDS        surfactant                                      complications CPAPMV            ...
Romanian National Registry for RDSResults after 1 year (2011):• 9 participating centres (8 level III + 1 level II)• 673 pr...
Romanian National Registry for RDSResults after 1 year (2011):• Institutional self-evaluation of the data• Comparison of t...
Romanian National Registry for RDSResults after 1 year (2011):- 4 presentation at international meetings, 2 published pape...
Romanian National Registry for RDSFebruary 2012 – evaluation:• New members in 2011:   • 5 level III centres   • 1 level II...
Romanian National Registry for RDS         The International Neonatology Conference, Kyiv 2013
Romanian National Registry for RDSResults after 2 years (2012):• 15 participating centres (13 level III + 2 level II)• 130...
Romanian National Registry for RDSFebruary 2012 – evaluation of the old system of data collection  and problems with:• Col...
Romanian National Registry for RDS         The International Neonatology Conference, Kyiv 2013
Romanian National Registry for RDS         The International Neonatology Conference, Kyiv 2013
Romanian National Registry for RDS         The International Neonatology Conference, Kyiv 2013
Romanian National Registry for RDS         The International Neonatology Conference, Kyiv 2013
Romanian National Registry for RDS         The International Neonatology Conference, Kyiv 2013
Romanian National Registry for RDSNew aims:• Identify new areas that need data collection & research• Generate new knowled...
Romanian National Registry for RDSNew aims:• Evaluation of the needs:   • Financial &   • Equipment &   • Human &   • Educ...
Romanian National Registry for RDSEvaluation in 2013:• National:   • 4 new centers – all level III   • Now: 19 centers (17...
Romanian National Registry for RDS         The International Neonatology Conference, Kyiv 2013
• Regionalization of the Mother and Newborn Care          • National Guidelines for ObGyn & Neonatology                   ...
The International Neonatology Conference, Kyiv 2013
Thank you!The International Neonatology Conference, Kyiv 2013
Upcoming SlideShare
Loading in …5
×

Romanian experience: regionalization, guidelines, National RDS Registry

457 views

Published on

International conference «Actual approaches to the extremely preterm babies: International experience and Ukrainian realities» (Kyiv, Ukraine, March 5-6, 2013)

Published in: Health & Medicine
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
457
On SlideShare
0
From Embeds
0
Number of Embeds
10
Actions
Shares
0
Downloads
5
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Romanian experience: regionalization, guidelines, National RDS Registry

  1. 1. Romanian experience:regionalization, guidelines, National RDS Registry Maria Livia Ognean Sibiu, Romania on behalf of the Romanian Association of Neonatology The International Neonatology Conference, Kyiv 2013
  2. 2. Romanian modern Neonatology• 1994 – residency in Neonatology• 1993 – 2005 - Newstart I, II, III: • Humana Foundation • Workshops, team work • Teams from Kentucky, Iowa, Pennsylvania, California, Virginia, Arizona • Romanian-American Symposiums (7) The International Neonatology Conference, Kyiv 2013
  3. 3. Romanian modern Neonatology• 1996 • Romanian Association of Neonatology • Neonatologia – the journal of the Romanian Association of Neonatology • Equipments and training acquired via World Bank • National Programs for neonatology (Health Ministry) • 1996 - Romanian Neonatology Conferences (16) & Congresses (2) The International Neonatology Conference, Kyiv 2013
  4. 4. Romanian modern Neonatology• 2000 - RoNeoNat – Romanian Swiss Program: • Neonatology training workshops • Quality management• 2003/2004 – Romanian Neonatology Guidelines • First clinical guidelines in Romania• Romanian programs and collaborations: • From 2007: Romanian Vojta Society • From 2009: Moldavian-Romanian Regional Conferences • Romanian Society of Obstetrics & Gynecology, Romanian Association of Perinatal Medicine • Annual training sessions, workshops • International: USA, R. Moldova, Bulgaria, Serbia, Russia The International Neonatology Conference, Kyiv 2013
  5. 5. Romanian Regionalization of the Perinatal Care• 2002 – Government Decision 534/30.05.2002 regarding the strategy for rehabilitation and reorganization of the obstetrical, gynecological and neonatal medical hospital care in Romania• 2002 – Order of the Health and Family Ministry regarding the grading criteria for the obstetrical, gynecological and neonatal hospital departments • ObGyn & Neo units level 0, I, II, III: – Competencies, organizations, human resources, minimal equipment, communications, transport • Common Standards for Neonatal Resuscitation and Transport The International Neonatology Conference, Kyiv 2013
  6. 6. Romanian Regionalization of the Perinatal Care2006 - Public Health Ministry:• Order 1778/28.12.2006: regarding the norms for human resources in hospitals• Order 1881/21.12.2006: establishing the grading of the hospital units, compartments, and departments of obstetrics, gynecology, and neonatology: • 86 level Ia • 59 level Ib • 41 level 2 • 20 level 3 The International Neonatology Conference, Kyiv 2013
  7. 7. Romanian Regionalization of the Perinatal CareFrom 2006:• Step-by-step implementation of the regionalization• Main obstacles: • Insufficient staff in the level III units • Low rate of submissions from level I to level II units • DRG reimbursements • Occurrence of the private maternity hospitals – not graded yet • Insufficient neonatal cardiac surgery and neurosurgery departments The International Neonatology Conference, Kyiv 2013
  8. 8. Next step: Neonatology Clinical Guidelines• National Neonatology Guidelines • Romanian Association of Neonatology • Update of the old guidelines • New guidelines – starting from 2009• Guideline = document developed according to a special methodology in order to help physicians to take rational decisions, according to specific clinical circumstances; • the statements of the guidelines are systematically elaborated based on scientific evidences The International Neonatology Conference, Kyiv 2013
  9. 9. National Neonatology Clinical Guidelines• Reasons & Aims: • Reducing neonatal morbidity & mortality • Natural continuation of the regionalization process • More efficient use of human, financial & equipment resources The International Neonatology Conference, Kyiv 2013
  10. 10. National Neonatology Clinical Guidelines• Working Groups: • Coordinating Group • Technical Groups for each guideline: – Writer – Editing & Technical support team – Coordinator • Reviewers • Integrator The International Neonatology Conference, Kyiv 2013
  11. 11. National Neonatology Clinical Guidelines• SIGN methodology for the guidelines development• AGREE instrument for the review of the guidelines The International Neonatology Conference, Kyiv 2013
  12. 12. Methodology for the guidelines development: Subject selection Working Group constitution Systematic review of the literature Elaboration and grading of the recommendations Internal review Health Integrator review Ministry Consensus Medical Colledge Institutional approvals Editing & Dissemination Implementation Periodical review The International Neonatology Conference, Kyiv 2013
  13. 13. National Neonatology Clinical Guidelines• SIGN methodology for the guidelines development: • What (how), who, when? • Levels of evidenceLevel Ia Evidence from the meta-analysis of randomized controlled studiesLevel Ib Evidence from at least one randomized controlled study, well structuredLevel IIa Evidence from at least one clinical controlled, not randomized, well structured studyLevel IIb Evidence from at least an quasi-experimental, well structured study, preferably multicenterLevel III Evidence from descriptive, well structured studiesLevel IV Evidence from expert committees or clinical experience of recognized experts as authorities in that field The International Neonatology Conference, Kyiv 2013
  14. 14. National Neonatology Clinical Guidelines• SIGN methodology for the guidelines development: • What (how), who, when? • Grading the evidence Grade A At least one randomized, controlled study as part of a list of quality studies published on the subject of the recommendation (level of evidence Ia or Ib). Grade B At least some well controlled clinical studies, not randomized, published on the subject of the recommendation (level of evidence IIa, IIb, or III). Grade C Evidence from reports or opinions of expert committees or from the clinical experience of recognized authorities in the subject filed (level of evidence IV). Indicates lack of good quality clinical studies on the subject of the recommendation. Grade E Good practice recommendations based on the clinical experience of the editing working group of the guideline. The International Neonatology Conference, Kyiv 2013
  15. 15. National Neonatology Clinical Guidelines• SIGN methodology for the guidelines development: • What (how), who, when? • Grading the recommendations Standard Norms that have to be rigidly applied and must be followed in almost all the cases, exceptions being rare and hard to justify. Recommendation Norms with low level of flexibility, less powerful than standards. When not applied this has to be rationally, logically justified, and documented. Option Neutral as regards choosing a conduct, indicates that multiple types of interventions exist and that different physicians may take different decisions. Options may contribute to teaching process and don’t need justification. The International Neonatology Conference, Kyiv 2013
  16. 16. National Neonatology Clinical Guidelines• Health Ministry Order 1232/02.08.2011 regarding the approval of Medical Practice Guidelines in Neonatology • 15 approved guidelines The International Neonatology Conference, Kyiv 2013
  17. 17. National Neonatology Clinical Guidelines• Guidelines in progress: • Volume 2: – Parenteral nutrition of the preterm infant – Neonatal hypotension – Neonatal hypertension – Persistent ductus arteriosus in preterm infants – Apnea – Transient tachypnea – Air leak syndromes – Chronic lung disease of the prematurity – Thrombocytopenia in newborns – Polycythemia – Metabolic bone disease of the prematurity – Newborn of the diabetic mother – Hypoxic-ischemic encephalopathy • Planned titles: 28 The International Neonatology Conference, Kyiv 2013
  18. 18. Next step: National Registry for RDS• 2010: Romanian Association of Neonatology • Support from Chiesi Romania • Conceived as a database • Voluntary • Non-profit • Confidential • On line, electronic • Data collection – retrospective in 2010 – prospective starting 2011 The International Neonatology Conference, Kyiv 2013
  19. 19. Romanian National Registry for RDS The International Neonatology Conference, Kyiv 2013
  20. 20. Romanian National Registry for RDSAims:• Improvement of the medical care for neonates and their families • Quality & safety • Effectiveness & efficiency • Identifying problems and need for study/research• Uniformity of the high quality standards of care• Promoting updated and new guidelines • Integrating research/EBM into practice The International Neonatology Conference, Kyiv 2013
  21. 21. Romanian National Registry for RDSOpportunities:• Cross-institutional collaboration• Benchmarking (search for the best practices that lead to better performance)• Estimation of the needs/resources: • Financial • Equipment • Human • Educational The International Neonatology Conference, Kyiv 2013
  22. 22. Romanian National Registry for RDSDatabase conceived to:• Document performances• Compare strategies• Compare outcomes• Identify opportunities for improvement• Monitor the succes The International Neonatology Conference, Kyiv 2013
  23. 23. Romanian National Registry for RDSDatabase:• Epidemiological data• Management/care, focused on: • Birth resuscitation • RDS treatment • Complications• Outcome of the preterm infants ≤ 32 wk GA admitted by the participating hospitals The International Neonatology Conference, Kyiv 2013
  24. 24. Romanian National Registry for RDSDatabase - structured to provide realiable and confidential data for the:• Quality management• Promotion of the: • New guidelines • Implementation of hospital protocols• Audit of the protocols and guidelines• Research/epidemiological studies • Grants & studies support• Educational platform The International Neonatology Conference, Kyiv 2013
  25. 25. Romanian National Registry for RDS The International Neonatology Conference, Kyiv 2013
  26. 26. Romanian National Registry for RDS The International Neonatology Conference, Kyiv 2013
  27. 27. Romanian National Registry for RDS The International Neonatology Conference, Kyiv 2013
  28. 28. Romanian National Registry for RDS epidemiological data antenatal steroids regionalization birth asphyxia/resuscitation The International Neonatology Conference, Kyiv 2013
  29. 29. Romanian National Registry for RDS surfactant complications CPAPMV discharge/death The International Neonatology Conference, Kyiv 2013
  30. 30. Romanian National Registry for RDSResults after 1 year (2011):• 9 participating centres (8 level III + 1 level II)• 673 preterm infants ≤ 32 wk GA enrolled • from 30292 live births – 2,22% • from 4150 live births ≤ 37 wk GA – 13,70%• GA – 24-32 wk GA• BW – 570-2490g• 14,28% coverage - 30292/212199 live births The International Neonatology Conference, Kyiv 2013
  31. 31. Romanian National Registry for RDSResults after 1 year (2011):• Institutional self-evaluation of the data• Comparison of the results• Institutions reported changes in attitudes • starting from completing data in the patient charts • ... discussions with OB about antenatal steroids • ... need for implementing protocols • ... minor changes of the database The International Neonatology Conference, Kyiv 2013
  32. 32. Romanian National Registry for RDSResults after 1 year (2011):- 4 presentation at international meetings, 2 published papers- “News in the Care of the Preterm Infant Born at less than 32 Weeks’ Gestation” - Neonatology Session at the National Congress of Pediatrics, Bucharest – 2011 • 11 presentations based on RDS Registry Data- “News in the Care of the Preterm Infant with less than 1000g Birth Weight (National Registry for Respiratory Distress Syndrome) – Session at the EuroRegional Conference of Neonatology, Timisoara, 2011 • 11 reports The International Neonatology Conference, Kyiv 2013
  33. 33. Romanian National Registry for RDSFebruary 2012 – evaluation:• New members in 2011: • 5 level III centres • 1 level II centre• Need for more data on: • Nutrition • Infection• Aims: more comprehensive evaluation of the problems associated with RDS and prematurity The International Neonatology Conference, Kyiv 2013
  34. 34. Romanian National Registry for RDS The International Neonatology Conference, Kyiv 2013
  35. 35. Romanian National Registry for RDSResults after 2 years (2012):• 15 participating centres (13 level III + 2 level II)• 1309 preterm infants ≤ 32 wk GA enrolled • from 45966 live births – 2.84% • from 5829 live births ≤ 37 wk GA – 12.68%• GA – 23-32 wk GA• BW – 450-2490g• 23.41% coverage - 45966/196.373 live births The International Neonatology Conference, Kyiv 2013
  36. 36. Romanian National Registry for RDSFebruary 2012 – evaluation of the old system of data collection and problems with:• Collecting• Submitting• Statistical analysisProposed changes of the database approved by participating hospitals The International Neonatology Conference, Kyiv 2013
  37. 37. Romanian National Registry for RDS The International Neonatology Conference, Kyiv 2013
  38. 38. Romanian National Registry for RDS The International Neonatology Conference, Kyiv 2013
  39. 39. Romanian National Registry for RDS The International Neonatology Conference, Kyiv 2013
  40. 40. Romanian National Registry for RDS The International Neonatology Conference, Kyiv 2013
  41. 41. Romanian National Registry for RDS The International Neonatology Conference, Kyiv 2013
  42. 42. Romanian National Registry for RDSNew aims:• Identify new areas that need data collection & research• Generate new knowledge and evidence for practice• Audit of the guidelines and protocols• Revision of the guidelines based on international EBM & national data• Structured information for the parents The International Neonatology Conference, Kyiv 2013
  43. 43. Romanian National Registry for RDSNew aims:• Evaluation of the needs: • Financial & • Equipment & • Human & • Educational• Better use of existent funding and resources• Finding new partners • National • Regional The International Neonatology Conference, Kyiv 2013
  44. 44. Romanian National Registry for RDSEvaluation in 2013:• National: • 4 new centers – all level III • Now: 19 centers (17 level III, 2 level II)• International: • After presenting the Registry at the 3rd Balkan Interdisciplinary Medical Forum “Innovative Technologies in Health Care”, Montenegru, April 2013: – Collaboration with Serbia and Russia• Over 20 new presentations & papers presented at national & international meetings The International Neonatology Conference, Kyiv 2013
  45. 45. Romanian National Registry for RDS The International Neonatology Conference, Kyiv 2013
  46. 46. • Regionalization of the Mother and Newborn Care • National Guidelines for ObGyn & Neonatology • RDS Registry= sustained & continuous effort of the healthcare professionals for a better quality & safer care of the newborns and their families The International Neonatology Conference, Kyiv 2013
  47. 47. The International Neonatology Conference, Kyiv 2013
  48. 48. Thank you!The International Neonatology Conference, Kyiv 2013

×