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Learning from Confidential Enquiries: New systems and feedback

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1 Learning from Confidential Enquiries: New systems and feedback
Heather Reid

2 Overview History to date Learning New processes – MBRRACE
Maternal Programme Perinatal Programme Confidential Enquiry

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4 Understanding and learning
History Confidential Enquiry into Maternal Deaths (CEMD) – 1952 Confidential Enquiry into Sudden Deaths in Infancy (CESDI) – 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

5 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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10 Confidential Enquiry Maternal and Infant Clinical Outcome Review Programmes (CORPs)

11 Confidential Enquiry Enquiries 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 The principal precursor to NCEPOD was a confidential and anonymous pilot study of mortality associated with anaesthesia (Lunn and Mushin, 1982). This covered inpatients from five regions in England, Wales and Scotland. Its aims were to assess perioperative information in order that the clinical practice of anaesthesia might be improved and to provide comparative figures between regions to facilitate this. A further important objective was to establish an index of contemporary standards of care to permit future comparisons. It had hoped that this study might be a combined surgical and anaesthetic enterprise but this proved impossible. In 1982 a joint venture between surgical and anaesthetic specialties named the Confidential Enquiry into Perioperative Deaths (CEPOD) was initiated. This reviewed surgical and anaesthetic practice over one year in three regions. In 1988 the National Confidential Enquiry into Perioperative Deaths (NCEPOD) was then established supported by government funding, and its first report was published in Since its inception NCEPOD has moved from reviewing the care of surgical patients and now covers all specialties. This is reflected in the wide range of studies we are currently undertaking. We also look at near misses rather than just death and have increased the number of reports we publish each year.

12 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 work!!!

13 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

14 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

15 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 I think you know a lot about the secure data entry system and you only need to say what is on the slide. The added value of electronic data capture – well you could say a lot about this but there are lots of things you can do in terms of monitoring the data coming in and looking at completeness and data quality – enabling print outs of individual cases and the development of tables of output for individual Units. Obviously in addition to national reports which are not mentioned here then plan is to produce Unit based reports with risk adjusted mortality rates designed to reflect variations in outcomes not just simply the effects of case-mix This will lead on to the identification of outliers and you know all about working with Units to resolve the data errors before escalation and the NAGCAE protocol. For the CEs we completed a joint UK Obstetric Surveillance System (UKOSS) and British Association of Paediatric Surgeons – Congenital Anomalies Surveillance System (BAPS-CASS) study recently and we will use the cases reported in these studies as our source of cases to sample. We are not reviewing all cases (which is what CMACE typically did – for no good reason) in this qualitative process of review. We run both UKOSS and BAPS-CASS at the NPEU.

16 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 I think you know a lot about the secure data entry system and you only need to say what is on the slide. The added value of electronic data capture – well you could say a lot about this but there are lots of things you can do in terms of monitoring the data coming in and looking at completeness and data quality – enabling print outs of individual cases and the development of tables of output for individual Units. Obviously in addition to national reports which are not mentioned here then plan is to produce Unit based reports with risk adjusted mortality rates designed to reflect variations in outcomes not just simply the effects of case-mix This will lead on to the identification of outliers and you know all about working with Units to resolve the data errors before escalation and the NAGCAE protocol. For the CEs we completed a joint UK Obstetric Surveillance System (UKOSS) and British Association of Paediatric Surgeons – Congenital Anomalies Surveillance System (BAPS-CASS) study recently and we will use the cases reported in these studies as our source of cases to sample. We are not reviewing all cases (which is what CMACE typically did – for no good reason) in this qualitative process of review. We run both UKOSS and BAPS-CASS at the NPEU.

17 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

18 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

19 Performance monitoring – funnel plots
Unadjusted Adjusted

20 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)

21 Current Structure – Northern Ireland
NIMACH DHSSPSNI 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

22 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

23 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 Almost 60 years - longest running enquiry in the world Strong evidence to suggest relationship between publication of report recommendations and subsequent reduction in deaths from pulmonary embolism – also influenced by advances in technology. Decline against a background of increasing birth rates and complexities in demographics, busy services etc – older mothers, more complex morbidity – some other countries such as US are experiencing a rise in maternal death. Powerful force in improving maternity services ROI included for 1st time MDR is about understanding – not just counting – like air craft investigations

24 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”

25 The maternal mortality or morbidity surveillance cycle
1. Identification of cases 2. Information collection 5. Evaluation and refinement 3. Analysis of results 4. Recommendations for action

26 UK Mortality Rates – Rise in 90s and early 2000 possibly due to improved case ascertainment

27 Maternal Death – UK Significant reduction in direct deaths – thromboembolism, haemorrhage

28 Direct & Indirect Rates
Thromboembolism (direct deaths) – One of the key strengths of the process is to identify trends in maternal mortality – if there is an increase in deaths due to one particular cause – than this can prompt the development of guideliens/processes to address it – development of thromboebmolism guidelines 2006/08

29 Leading Cause Maternal Death 2006-08
Cardiac disease, pre existing medical conditions Direct deaths – now sepsis with preeclampsia in 2nd place – this is a change from last report where thromboembolism was the leading cause (now 3rd)

30 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

31 Back to Basics Guidance 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. “Back to Basics” identification and management of • Pyrexia and post natal pyrexia, • Sore throats • Pain • Abdominal pain and D & V Saving Mothers’ Lives , National launch - March 2011 • Breathlessness • Headache • Anxiety and distress o Good mental health practice • Unexplained physical symptoms

32 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

33 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 65 (50%) 2013 57 34 (60%) Total 534

34 Maternal Death ~100 maternal deaths (11 per 100,000 maternities)

35 Maternal Morbidity and Mortality Annual Report Topics
Year 1 (2014): Sepsis, haemorrhage, amniotic fluid embolism, anaesthetic, neurological, other indirect (deaths ) Year 2:, Psychiatric, thrombosis, other direct, late and coincidental Year 3: Pre-eclampsia and eclampsia, cardiac, early pregnancy

36 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

37 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

38 Perinatal Mortality - UK

39 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)

40 Northern Ireland – Perinatal Mortality Reports

41 Stillbirth, perinatal and neonatal mortality rates (crude) and Total births, Northern Ireland ~ 2001 – 2013

42 Northern Ireland

43 Stillbirth Rate – Northern Ireland – 2001 - 2012

44 Stillbirth – Northern Ireland

45 Neonatal Death – Northern Ireland – 2001 - 2012

46 Neonatal Death – Northern Ireland 2001 - 2012

47 Time of death

48 Deaths associated with factors known to increase risk of mortality: Northern Ireland Births 2007 – 2012

49 Stillbirths Associated with High Risk Factors

50 Neonatal deaths associated with high risk factors

51 Stillbirth by gestation – Northern Ireland - 2012

52 Neonatal Death by Gestation – Northern Ireland - 2012

53 Risk factors - BMI

54 Confidential Enquiries

55 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

56 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.

57 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) call for topic proposals is open until 31st Dec 2013

58 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

59 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.)

60 HQIP cause for concern guidance
Assessors 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.

61 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

62 Key standards - sepsis Recognition Response and management
RCOG Green-top Guideline 64a: Bacterial sepsis in pregnancy: Sections 5 and 6 RCOG Green-top Guidelines 64b: Bacterial sepsis following pregnancy: Section 7 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 Investigations Surviving Sepsis Campaign Bundles: (http://www.survivingsepsis.org/bundles/Pages/default.aspx) 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

63 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) I think you know a lot about the secure data entry system and you only need to say what is on the slide. The added value of electronic data capture – well you could say a lot about this but there are lots of things you can do in terms of monitoring the data coming in and looking at completeness and data quality – enabling print outs of individual cases and the development of tables of output for individual Units. Obviously in addition to national reports which are not mentioned here then plan is to produce Unit based reports with risk adjusted mortality rates designed to reflect variations in outcomes not just simply the effects of case-mix This will lead on to the identification of outliers and you know all about working with Units to resolve the data errors before escalation and the NAGCAE protocol. For the CEs we completed a joint UK Obstetric Surveillance System (UKOSS) and British Association of Paediatric Surgeons – Congenital Anomalies Surveillance System (BAPS-CASS) study recently and we will use the cases reported in these studies as our source of cases to sample. We are not reviewing all cases (which is what CMACE typically did – for no good reason) in this qualitative process of review. We run both UKOSS and BAPS-CASS at the NPEU.

64 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

65 Reality check?

66 and finally……….any Questions?
“Tell me and I forget, teach me and I may remember, involve me and I learn.”  Benjamin Franklin

67 NIMACH Office Office based within Public Health Agency, Linenhall Street, Belfast Heather Reid, Regional Manager: Joanne Gluck, Clinical Research Midwife: Malcolm Buchanan, Administrator: Telephone number:


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