02. CDH Background and development of the enquiry Dec

Background & development of
the 2013 Perinatal
Confidential Enquiry into CDH
Professor Elizabeth S Draper
11th December 2014
What is a confidential enquiry?
– Health service evaluation of care provision
against the current standards / guidelines
– Qualitative method
– Anonymous case review
– Multidisciplinary panel consensus
– To identify preventable factors and suboptimal care
– To identify examples of good quality care
– Disseminate findings / recommendations
• 1991 – DH directive: regional perinatal mortality surveys
• 1993 – national confidential enquiries into perinatal deaths:
CESDI (DH funded)
• 1996 – management by consortium of Royal Colleges
• 2003 – restructuring: CEMACH
• 2009 – organisational change: CMACE
• 2009 – commissioning changed to NPSA
• 2010 – competitive tender MNI-CORP
– MBRRACE-UK were successful
– Procurement halted March 2011 - to enable a review (reported July)
• 2011 – 31st March CMACE closed
• 2012 – 30th May MBRRACE-UK commissioned by HQIP
Aims of the MBRRACE-UK
confidential enquiries:
• Deliver confidential case reviews to:
– Assess quality and safety of maternity and infant
– Support improvements in service quality through
national learning
– Produce evidence-based recommendations and
good practice points
– Influence clinical practice, service provision,
health policy and clinical education
Choice of Confidential Enquiry topic
Annual process
• Autumn open call via website and key stakeholder
groups for topic using standard form.
• January (following year) sifting by MBRRACE team
to identify submissions that could be carried out
using a confidential enquiry format.
• February – MBRRACE team and IAG meet and vote
to select a shortlist of 4.
• March topic chosen from shortlist by IAG for
confidential enquiry the following year.
• 2013 –congenital diaphragmatic hernia
• 2014 – normally formed singleton unexpected
antepartum stillbirth at term
• 2015 – intrapartum deaths
• Previously investigated by CESDI for babies >2.5kg & >1.5kg
• 2016 – multiple births
Topic choice for 2013:
Congenital diaphragmatic hernia
• Sampling frame – anonymised cases
• UK wide epidemiological study
of CDH in 2009/2010.
• High rates of mortality & morbidity
• Multi-disciplinary care provision
• No previous CE on this topic
• Chosen by Independent Advisory Group
Information sources
• BAPS-CASS (British Association of Paediatric Surgeons
– Congenital Anomaly Surveillance System)
– Monthly card notification - all 28 paediatric surgical units UK & RI
• UKOSS (UK Obstetric Surveillance System)
– Monthly card notification - all 221 consultant led UK obstetric units
• BINOCAR (British Isles Network of Congenital Anomalies
– 8 regional congenital anomalies registers - 45% UK births
– Multi-source notification system (AN & PN diagnosis + all outcomes)
What is CDH?
• Results from failure of normal development of the
diaphragm in first trimester.
• Three types....
– Complete absence of the diaphragm (rare & most
– Failure of normal development of the anterior
diaphragm (2%)
– Failure of closure of posterior diaphragm (most
common – 85% left-sided; 10% right; 5% bilateral)
Congenital diaphragmatic hernia
Defect in left diaphragm
Normal anatomy
Epidemiology of CDH
• Birth prevalence
EUROCAT data 1980-2009: analysis by NorCAS.
UK rate 2.5 to 3.4 / 10,000 total births
Equivalent to 1 in 3000 to 4000 births
EUROCAT data 1980-2009: analysis by NorCAS.
Epidemiology of CDH
Birth prevalence : 1 in 3000 to 4000 live births
Small increase in prevalence over last 30 years
UK cases per annum 200 to 300
Antenatal diagnosis 70% --- FASP target 60%
Approx 15% TOPs
Approx 80% live born
What happens to live born babies
with CDH?
Died before surgery
Died after surgery
Alive after surgery
Epidemiology of CDH
Birth prevalence : 1 in 3000 to 4000 live births
Small increase in prevalence over last 30 years
UK cases per annum 200 to 300
Antenatal diagnosis 70% --- FASP target 60%
Approx 15% TOPs
Approx 80% live born
CDH isolated anomaly – 70% cases
– 10% associated with chromosomal or genetic
syndrome (eg. Trisomy 13 or 18, Fryn’s syndrome)
– 20% structural anomalies including: cardiac, CNS, limb
Specific aims of the CDH enquiry
• To assess UK quality of care provision for:
– pregnancies affected by CDH
– babies diagnosed with CDH : antenatal & postnatal
• To identify aspects of sub-optimal care &
excellent practice
• To review care provision against consensus
views of best practice across UK (TEG)
• To identify recurring themes for potential
improvement in care provision
Topic Expert Group & Panel
• Open invitation to participate – key stakeholder
groups – CDH interest / expert:
Fetal medicine
Neonatal medicine
Paediatric surgery
Neonatal nursing
Congenital anomaly registers
Lay representative from CDH UK
Topic Expert Group - remit
• Identify the appropriate standards of care
against which cases should be assessed
• Develop an enquiry assessment tool
• Advise MBRRACE-UK writing group on
appropriate evidence-based actions to address
the lessons learned from the confidential case
• Peer review resulting report / recommendations
CDH care pathway
• No robust evidence in literature
• No established care pathway
• TEG consensus
– aspects of good practice along care pathway
CDH care pathway cont:
• Diagnosis & Screening Issues
• Delivery
• Resuscitation
• Early after-care
• Surgery & post-operative care
• Palliative care issues –either antenatal or postnatal
where appropriate
• Long-term outcome
Diagnosis & screening:
• Was screening carried out at the appropriate time?
• Did the mother decline screening, or book into antenatal
care late in the pregnancy? Was referral appropriate and
timely (taking into account geographical location)?
• Was counselling documented as regards content and
with the appropriate multidisciplinary team?
• Was there evidence that the counselling was provided in
a way to meet the mother’s / family’s needs including, if
appropriate, access to a multidisciplinary team?
• Was sufficient time given for the decision-making
Diagnosis, screening & delivery:
Good clinical practice would include:
• Anomaly scan at 18+0 - 20+6 weeks gestation - FASP.
• Offer of invasive testing for chromosome anomalies
• Suspected CDH on scan – mother reviewed by specialist
clinician to confirm & discuss diagnosis including specialist
scanning to exclude other congenital anomalies. Timescale –
same hospital 3 days or referral to FM centre within 5 days of
• Once diagnosis confirmed – offer of MDT meet with parents in
the relevant tertiary centre - provision of written & verbal
• Offer of counselling to facilitate decision making – adequate
time given to consider options eg. TOP. Parental choice
supported by MDT.
• Information re: alternative sources of support, e.g. CDH UK,
Antenatal Results & Choices (ARC), HealthTalkOnline, etc.
CDH care pathway cont:
• Diagnosis & Screening Issues
• Delivery
• Resuscitation
• Early after-care
• Surgery & post-operative care
• Palliative care issues –either antenatal or postnatal
where appropriate
• Long-term outcome
Evaluation of Care
• Good care; no improvements identified
• Improvements in care* identified which would have made
no difference to outcome
• Improvements in care* identified which may have made
a difference to outcome
• HQIP Cause for Concern Guidance (page 5)
*Improvements in care should be interpreted to include adherence to guidelines where
these exist and have not been followed, as well as other improvements which would
normally be considered as part of good care, where no formal guidelines exist.
CDH panel enquiry process
• Stratified random sample UKOSS / BAPS-CASS
– By UK country
– Timing of diagnosis
– Outcome
• Delivered in 2009 – 2010
• n = 67 cases
• Modified CESDI process for mortality & morbidity
*Draper ES et al 2002, ADC FNN; 87:F176-F180
Acquiring case notes
• Cases in UKOSS / BAPS-CASS anonymised
• Units contacted using data re: hospital of care,
notifier, date of operation / delivery
• NIMACH office for NI cases
• Initially case notes requested to be copied &
anonymised in unit – clear instructions provided &
• New amendment to CAG to allow Leicester office to
anonymise notes
• Checked for completeness on arrival in Leicester
Preparation for panel meetings
• Availability of multidisciplinary panel members
• Case notes uploaded to secure MBRRACE-UK webbased high compliance system
• Email to panel members 3-4 week prior to date of
enquiry panel – access to relevant notes
• Lead presenter identified for each case
• TEG guidance document provided
• Panel members to review all cases, complete the
case evaluation sheet & overall evaluation of care
CDH panel meetings
• Face to face discussions
• Day meetings
• Central location
• Up to 9 CDH cases per panel
• Neutral chair: Elizabeth Draper / David Field
• Facilitator: Pauline Hyman-Taylor
• Presentation of each case followed by
consensus discussion.
• Collection of all forms & preparation documents
from panel members

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