learning from confidential enquiries: new systems and feedback heather reid
TRANSCRIPT
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Learning from Confidential Enquiries:New systems and feedback
Heather Reid
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Overview
• History to date• Learning • New processes – MBRRACE• Maternal Programme• Perinatal Programme• Confidential Enquiry
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History• Confidential Enquiry into Maternal Deaths (CEMD) – 1952
• Confidential Enquiry into Sudden Deaths in Infancy (CESDI) – 1992-93
• Confidential Enquiry into Maternal and Child Health (CEMACH) was formed in April 2003
• Centre for Maternal and Child Health (CMACE) -2008
• Mothers and Babies Reducing Risk through Audit and Confidential Enquiry (MBRRACE)
Understanding
and learning
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Learning
• Definition - the acquisition of knowledge or skills through study, experience, or being taught (Oxford Dictionary)
“Any fool can know. The point is to understand.” ― Albert Einstein
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Confidential Enquiry
• Maternal and Infant Clinical Outcome Review Programmes (CORPs)
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Confidential EnquiryEnquiries commissioned by Healthcare Quality Improvement
Partnership (HQIP)
• National Confidential Enquiry into Patient Outcome and Death - NCEPOD (1982)
• National Confidential Inquiry into Suicide and Homicide by People with Mental Illness - NCISH (1992)
• Confidential Enquiry into Maternal Infant and New-born and Maternal Death
• Confidential Enquiry into Child Death (1952)
– Tendered In April 2010 under European procurement legislation (£694,000 per year).
– Procurement halted March 2011 (CMACE closed April 2011) – interim web portal for England and Wales – NI – business as usual!
– MBRRACE contract signed 1st June 2012 – End date: 31st March 2015/2017
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Since June 2012• Checking all CMACE paper data for completeness• Requesting missing data• Collecting case notes for notified cases• Seeking clinicians reports for notified cases• Extracting surveillance data• Taking new notifications• Planning for Confidential Enquiry processes and Annual Reports• Recruiting and training specialist assessors: obstetrics,
midwifery, anaesthetics, intensive care, general practice, obstetric medicine, cardiology, neurology, pathology, psychiatry, emergency medicine
• Developing electronic systems for assessment• Planning morbidity confidential enquiries• Organising selection of new morbidity confidential enquiry topics
Lots of w
ork!!!
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MBRRACE-UK overarching aim
To provide robust UK-wide information to support service improvement in the delivery of:– Safe; equitable; high quality; patient-centred maternal,
newborn and infant health services
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Achieve this through UK-wide:• Surveillance and confidential enquiries of all maternal
deaths (to 1 year post pregnancy completion)• Confidential enquiries of a rolling programme of
serious maternal morbidity – severe maternal sepsis in 2013
• Surveillance of late fetal losses (22-23 weeks), stillbirths, neonatal and post-neonatal deaths
• Confidential enquiries of a rolling programme of infant mortality and serious infant morbidity – congenital diaphragmatic hernia in 2013
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Progress since June 2012• Secure electronic web-based data entry system – for the late
fetal losses, stillbirths and infant mortality data– Developed a secure web-based data entry system – data collection via the
internet – modifications in progress for NI data entry– Identified the information to be collected (reducing the items where possible)– Selected a new mortality classification system (CODAC) (expert advisory group –
including Dr Claire Thornton)– Tested and launched the system – April 2013 (for inclusion of cases from births
1st January 2013 onwards)– All Units in England, Wales and Scotland are registered– All Units (except two) in E, W & S entering cases
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• Added value of electronic data capture– Internal validation features– Print out of individual cases – file in the case notes, send to other data
recipients (CDOP/CDRs)– Assessment of data quality and completeness– Link to civil registration data (ONS) to assess completeness of case notification
Developmental:– Further internal data validation checks– Assessment of data quality and completeness (feed back to Units/NIMACH)– General modifications and improvements to the data entry– Units able download own dataset– Tabulated outputs of Unit based data for Units own audits
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Identification and management of outliers
• Primary objective – provide risk adjusted analyses to monitor performance and identify outliers
• Mortality data presented:– Including & excluding late fetal losses (22-23 weeks)– Excluding major congenital anomalies– By case type
• Analysis and presentation using:– Funnel plots – before & after risk adjustment– Analysis of means– Developing new methodologies
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Identification and management of outliers…..
• Analysis for stillbirths:– by unit type: tertiary / DGH– by stillbirth group– risk adjustment for plurality, ethnic group, deprivation (country-
specific IMD)
• Analysis for neonatal deaths:– by neonatal network /Unit – what is the correct level of analysis??– including / excluding transfers– risk adjustment for case mix, gestational age, ethnic group, deprivation
(country-specific IMD), plurality
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Performance monitoring – funnel plots
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NAGCAE Outlier Protocol*
• Alert – 2SD from the average• Alarm – 3SD from the average
– Unit checks data and send back report (25 days)– If data at fault – corrected, re-analysis – if okay close
• If data correct – notify clinical governance lead, medical director, chief executive; HQIP
• Chief executive to inform relevant bodies: CCGs, Care Quality Commission
• Public disclosure of comparative information
*National Advisory Group on Clinical Audit & Enquiries guidance, published by the Department of Health (England)
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Current Structure – Northern Ireland
NIMACH
DHSSPSNI
NIMACH Steering group - NIMI Stakeholders
•Trusts – Midwifery and obstetric services, neonatal intensive care, pathology•Professional groupings•Primary care•RQIA•HSC Safety Forum•QUB / UUJ•HSCB•HSCB/PHA Maternity/Paediatric & Child Health Commissioning Group
Public Health Agency
Service Development & Screening Division
Public Health Directorate
MBRACCE
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Northern Ireland Data Collection Process
• Surveillance:– Notifications from Trusts– Manual returns (PDN / Maternal Death Forms)– Sent to NIMACH office (follow up on missing data)– PMs, placental histology
• Unit Coordinators• Legal Requirements – Data Protection / Section
251/ Secondary Use of Data• Quality assurance – NISRA / GRO
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Maternal Death Programme
MDR philosophy….to recognise and respect every maternal death is a young woman who died before her time….goes beyond counting numbers to listen and tell stories…..so as to learn lessons that may save other mothers and babies
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Impact of Maternal Deaths
• Maternal deaths – women who loose their lives prematurely
• Live new-born deaths due to maternal causes• Existing children loose their mother• Existing children were in need of “care”
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1. Identification ofcases 2. Information
collection
5. Evaluation andrefinement
3. Analysis of results
4. Recommendationsfor action
The maternal mortality or morbidity surveillance cycle
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UK Mortality Rates – 1952-2008
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Maternal Death – UK 1985-2008
Significant reduction in direct deaths – thromboembolism, haemorrhage
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Direct & Indirect Rates
2006/08
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Leading Cause Maternal Death 2006-08
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Top 10 Recommendations• Pre pregnancy counselling• Professional interpretation services• Communications and referrals• Women with potentially serious medical conditions require immediate
and appropriate multidisciplinary care• Clinical skills and training• Specialist clinical care: identifying and managing very sick women• Systolic hypertension requires treatment• Genital tract infection/sepsis• Serious Incident Reporting and Maternal deaths• Pathology
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Back to BasicsGuidance to help with:
• Improving basic medical and midwifery practice, such as taking a history, undertaking basic observations and understanding normality.
• Attributing signs and symptoms of emerging serious illness to commonplace symptoms in pregnancy.
• Improving communication and referrals.
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MBRRACE
• Maternal death – highest priority for MBRRACE• Includes late maternal death – up to 1 year• Process of case ascertainment (estimate 85% deaths
captured to date – complete information on around 50%)
• Recruitment of specialist advisors to assess case notes• 1st MBRRACE Maternal Mortality Report – December
2014• Yearly reporting thereafter
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Notification and case note collection
Total cases known by year
Evaluated as complete
Cases with no notes of any kind
2009 114 91 (80%) 10 (9%)
2010 126 38 (30%) 10 (8%)
2011 106 Not yet evaluated 26 (25%)
2012 131 Not yet evaluated 65 (50%)
2013 57 Not yet evaluated 34 (60%)
Total 534
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Maternal Death - 2011
• ~100 maternal deaths (11 per 100,000 maternities)
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Maternal Morbidity and Mortality Annual Report Topics
• Year 1 (2014): Sepsis, haemorrhage, amniotic fluid embolism, anaesthetic, neurological, other indirect (deaths 2009-2012)
• Year 2:, Psychiatric, thrombosis, other direct, late and coincidental
• Year 3: Pre-eclampsia and eclampsia, cardiac, early pregnancy
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Perinatal and Infant Mortality
MBRRACE Changes• Inclusion of late fetal losses• Notification of neonatal death – 20 weeks or >500g
where gestational age not available• Extension to 1 year 9previously 28 days)
– 2013 confined to deaths in neonatal units only– 2014 plans to expand data collection to all deaths up to 1
year (different data set) • Links with Child Death Review (CDOP)• Coding / Classification
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Cause of death
• Challenges in coding systems (many unclassified)
• Limitations in comparisons between countries and across time
• CODAC (Cause of Death and Associated Conditions) – hierarchical tree of potential causes. Main cause of death is identified along with associated factors at three levels
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Perinatal Mortality - UK
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Perinatal Mortality Report - UK
• First UK ‘perinatal’ surveillance report of stillbirths and neonatal deaths in the 2013 UK-national birth cohort: May 2015 (delay due to access to the denominator data & deaths data for confirmation of completeness of case notifications)
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Northern Ireland – Perinatal Mortality Reports
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Stillbirth, perinatal and neonatal mortality rates (crude) and Total births, Northern Ireland ~ 2001 –
2013
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Northern Ireland
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Stillbirth Rate – Northern Ireland – 2001 - 2012
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Stillbirth – Northern Ireland
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Neonatal Death – Northern Ireland – 2001 - 2012
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Neonatal Death – Northern Ireland 2001 - 2012
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Time of death
Time between Birth and Death in ENND as percentage of total ENND2012 2011
<1 hr 27% 28%1-12 hr 38% 43%>12 hr 35% 29%
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Deaths associated with factors known to increase risk of mortality: Northern Ireland Births 2007 – 2012
2007 2008 2009 2010 2011 2012Gestation <22 weeks^ 0 0 0 0 0 0Lethal Malformations ^ 13 13 16 12 16 24Birth Weight <500g^ 5 3 7 8 8 9
Gestation <22 weeks^ 6 1 12 10 19 10Lethal Malformations ^ 27 16 34 37 31 29Birth Weight <500g^ 7 11 16 20 28 12
Gestation <22 weeks^ 0 0 0 0 0 0Lethal Malformations ^ 8 7 9 6 7 5Birth Weight <500g^ 0 0 0 0 1 0
Stillbirths
Early Neonatal Deaths
Late Neonatal Deaths
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Stillbirths Associated with High Risk Factors
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Neonatal deaths associated with high risk factors
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Stillbirth by gestation – Northern Ireland - 2012
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Neonatal Death by Gestation – Northern Ireland - 2012
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Risk factors - BMI
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Confidential Enquiries
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Uses of confidential enquiry data - Reasons
• Confidential enquiry is a qualitative approach: narrative-based medicine
• Describes not just the ‘what’ but the ‘why’• Detailed investigation of care against accepted standards• Does not generate new information to change evidence-
based practice, but does identify when current practice is not evidence-based
• Stories are powerful and can be uniquely persuasive in changing practice
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Confidential enquiry methodology
• Systematic, multi-disciplinary, anonymous review of all OR a sample of cases occurring in a defined population during a defined period of time;
• Where the numbers of a specific type of condition are small in number it is appropriate to review all the cases;
• Where numbers are large it is usual to take a sample of cases;• Review is by either individual or paired reviewers or during a panel
process; • Comparisons of care are made against guidelines, quality standards or
best practice where guidelines have not been developed;• The aim is to identify avoidable or remediable factors associated with the
cases so as to inform future practice and improvements in care which may make a difference to outcomes in the future.
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Confidential enquiry topics:• Serious maternal morbidity (report Dec 2014)
– 2013 maternal sepsis in 2013 (UKOSS sample of cases)
– 2014 postpartum psychosis in women who have a past psychiatric history of bipolar affective disorder or postpartum psychosis following a previous pregnancy (case sampling being explored)
– 2015 pregnancy in women with artificial heart valves (UKOSS)
• Infant mortality and serious infant morbidity (report mid 2014)– 2013 congenital diaphragmatic hernia (UKOSS/BAPS-CASS sample
of cases)
– 2014 unexpected antepartum stillbirth of a normally formed fetus at term (MBRRACE-UK sample)
– 2015 - call for topic proposals is open until 31st Dec 2013
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Confidential Enquiry Assessors• 16 Obstetricians• 19 Anaesthetists• 3 Obstetric Physicians• 4 Cardiologists• 2 Neurologists• 15 Midwives• 3 GPs• 7 Intensive care consultants• 1 Emergency medicine consultant• 8 Pathologists• 6 Psychiatrists• Infectious disease physicians TBA
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Assessment of care
Assessors are asked to assign cases to one of the following three categories after assessment:• Good care; no improvements identified as being needed• Improvements in care* identified which would have made no
difference to outcome• Improvements in care* identified which may have made a
difference to outcome
(*Improvements in care are interpreted to include adherence to guidelines, where these exist and have not been followed, as well as other improvements which would normally be considered part of good practice, where no formal guidelines exist.)
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HQIP cause for concern guidanceAssessors have been asked to flag cases a cause for concern according to HQIP protocol:
• Death (child or adult) attributable to abuse or neglect, in any setting, but no indication of cross agency involvement (i.e. no mention of safeguarding, social services, police or LSCB).
• Staff member displaying:– Abusive behaviour (including allegations of sexual assault)– Serious professional misconduct– Dangerous lack of competency– But not clear if incident has been reported to senior staff
• Standards in care that indicate a dysfunctional or dangerous department or organisation, or grossly inadequate service provision.
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Sepsis Confidential Enquiry progress
• Topic Expert Group convened• Key standards identified• 32 Cases selected (UKOSS sample) (2 from NI)• Case notes and local clinician reports requested
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Key standards - sepsis1. Recognition
– RCOG Green-top Guideline 64a: Bacterial sepsis in pregnancy: Sections 5 and 6– RCOG Green-top Guidelines 64b: Bacterial sepsis following pregnancy: Section 7
2. Response and management– Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic
Shock, 2012: Tables 5,6 and 8, Figure 1.– The Sepsis Six (http://survivesepsis.org/the-sepsis-six/): – RCOG Green-top Guideline 64a: Bacterial sepsis in pregnancy– RCOG Green-top Guidelines 64b: Bacterial sepsis following pregnancy
3. Investigations– Surviving Sepsis Campaign Bundles: (http
://www.survivingsepsis.org/bundles/Pages/default.aspx)
4. Condition-specific guidance– British Thoracic Society guidelines for the management of community acquired pneumonia in
adults: update 2009: Figure 8– Critical care management of adults with influenza with particular reference to H1N1 (2009)– Surgical site infection – NICE Guideline CG74 Prevention and treatment of surgical site infection
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CDH confidential enquiry• Planning the confidential enquiry work for the CDH cases
– Sample of 66 cases identified through a recent joint UKOSS and BAPS-CASS study
– Qualitative panel process guided by a care pathway developed by a Topic Expert Group (Dr Alyson Hunter, Royal Jubilee Maternity Hospital)
– Recruitment of panel members – Panels will be case specific – TOP, Stillbirths, Neonatal deaths, deaths post-
surgery, survivors following surgery– Dates for panels set– Training will be provided at the panels– Units have received requests for anonymised copies of selected case notes
shortly (5 sets received)
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Learning from surveillance and enquiry
• Room for improvement• Learn from others
• Challenges and barriers– Identifying preventable deaths– Understanding our data– Improving MDT mortality review– Service capacity – pathology, review
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Reality check?
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and finally……….any Questions?
“Tell me and I forget, teach me and I may remember, involve me and I learn.”
Benjamin Franklin
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NIMACH Office• Office based within Public Health Agency, Linenhall
Street, Belfast
• Heather Reid, Regional Manager: [email protected]
• Joanne Gluck, Clinical Research Midwife: [email protected]
• Malcolm Buchanan, Administrator: [email protected]
Telephone number: 028 90553611