Romanian experience: regionalization, guidelines, National RDS Registry

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

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)



• 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)



• 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

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


2006 - 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



From 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


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


National Neonatology Clinical Guidelines

• Reasons & Aims:
• Reducing neonatal morbidity & mortality
• Natural continuation of the regionalization process
• More efficient use of human, financial & equipment
resources



• Working Groups:
• Coordinating Group
• Technical Groups for each guideline:
– Writer
– Editing & Technical support team
– Coordinator
• Reviewers
• Integrator



• SIGN methodology for the guidelines development
• AGREE instrument for the review of the guidelines


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


• SIGN methodology for the guidelines development:
• What (how), who, when?
• Levels of evidence

Level Ia Evidence from the meta-analysis of randomized controlled studies

Level Ib Evidence from at least one randomized controlled study, well structured

Level IIa Evidence from at least one clinical controlled, not randomized, well
structured study
Level IIb Evidence from at least an quasi-experimental, well structured study,
preferably multicenter
Level III Evidence from descriptive, well structured studies
Level IV Evidence from expert committees or clinical experience of recognized
experts as authorities in that field



• 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.



• 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.



• Health Ministry Order 1232/02.08.2011 regarding the
approval of Medical Practice Guidelines in Neonatology
• 15 approved 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

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


Romanian National Registry for RDS



Aims:
• 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



Opportunities:
• Cross-institutional collaboration
• Benchmarking (search for the best practices that lead to
better performance)
• Estimation of the needs/resources:
• Financial
• Equipment
• Human
• Educational



Database conceived to:
• Document performances
• Compare strategies
• Compare outcomes
• Identify opportunities for improvement
• Monitor the succes



Database:
• Epidemiological data
• Management/care, focused on:
• Birth resuscitation
• RDS treatment
• Complications
• Outcome of the preterm infants ≤ 32 wk GA admitted by the
participating hospitals



Database - 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


epidemiological data
antenatal steroids

regionalization

birth asphyxia/resuscitation

surfactant complications

CPAP

MV

discharge/death


Results 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



• 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



- 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



February 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



Results 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



February 2012 – evaluation of the old system of data collection
and problems with:
• Collecting
• Submitting
• Statistical analysis
Proposed changes of the database approved by participating
hospitals



New 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



New aims:
• Evaluation of the needs:
• Financial &
• Equipment &
• Human &
• Educational
• Better use of existent funding and resources
• Finding new partners
• National
• Regional



Evaluation 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


• 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


Thank you!


Romanian experience: regionalization, guidelines, National RDS Registry

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Romanian experience: regionalization, guidelines, National RDS Registry