4 Understanding and learning HistoryConfidential Enquiry into Maternal Deaths (CEMD) – 1952Confidential Enquiry into Sudden Deaths in Infancy (CESDI) –Confidential Enquiry into Maternal and Child Health (CEMACH) was formed in April 2003Centre for Maternal and Child Health (CMACE) -2008Mothers and Babies Reducing Risk through Audit and Confidential Enquiry (MBRRACE)Understanding and learning
5 LearningDefinition - 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
10 Confidential EnquiryMaternal and Infant Clinical Outcome Review Programmes (CORPs)
11 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 DeathConfidential 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 2012End date: 31st March 2015/2017The 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 2012Checking all CMACE paper data for completenessRequesting missing dataCollecting case notes for notified casesSeeking clinicians reports for notified casesExtracting surveillance dataTaking new notificationsPlanning for Confidential Enquiry processes and Annual ReportsRecruiting and training specialist assessors: obstetrics, midwifery, anaesthetics, intensive care, general practice, obstetric medicine, cardiology, neurology, pathology, psychiatry, emergency medicineDeveloping electronic systems for assessmentPlanning morbidity confidential enquiriesOrganising selection of new morbidity confidential enquiry topicsLots 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 2013Surveillance of late fetal losses (22-23 weeks), stillbirths, neonatal and post-neonatal deathsConfidential enquiries of a rolling programme of infant mortality and serious infant morbidity – congenital diaphragmatic hernia in 2013
15 Progress since June 2012Secure electronic web-based data entry system – for the late fetal losses, stillbirths and infant mortality dataDeveloped a secure web-based data entry system – data collection via the internet – modifications in progress for NI data entryIdentified 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 registeredAll Units (except two) in E, W & S entering casesI 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-mixThis 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 featuresPrint out of individual cases – file in the case notes, send to other data recipients (CDOP/CDRs)Assessment of data quality and completenessLink to civil registration data (ONS) to assess completeness of case notificationDevelopmental:Further internal data validation checksAssessment of data quality and completeness (feed back to Units/NIMACH)General modifications and improvements to the data entryUnits able download own datasetTabulated outputs of Unit based data for Units own auditsI 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-mixThis 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 outliersMortality data presented:Including & excluding late fetal losses (22-23 weeks)Excluding major congenital anomaliesBy case typeAnalysis and presentation using:Funnel plots – before & after risk adjustmentAnalysis of meansDeveloping new methodologies
18 Identification and management of outliers….. Analysis for stillbirths:by unit type: tertiary / DGHby stillbirth grouprisk 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 transfersrisk adjustment for case mix, gestational age, ethnic group, deprivation (country-specific IMD), plurality
20 NAGCAE Outlier Protocol* Alert – 2SD from the averageAlarm – 3SD from the averageUnit checks data and send back report (25 days)If data at fault – corrected, re-analysis – if okay closeIf data correct – notify clinical governance lead, medical director, chief executive; HQIPChief executive to inform relevant bodies: CCGs, Care Quality CommissionPublic disclosure of comparative information*National Advisory Group on Clinical Audit & Enquiries guidance,published by the Department of Health (England)
21 Current Structure – Northern Ireland NIMACHDHSSPSNISteering group - NIMIStakeholdersTrusts – Midwifery and obstetric services,neonatal intensive care, pathologyProfessional groupingsPrimary careRQIAHSC Safety ForumQUB / UUJHSCBHSCB/PHA Maternity/Paediatric & Child Health Commissioning GroupPublic Health AgencyService Development &Screening DivisionPublic Health DirectorateMBRACCE
22 Northern Ireland Data Collection Process Surveillance:Notifications from TrustsManual returns (PDN / Maternal Death Forms)Sent to NIMACH office (follow up on missing data)PMs, placental histologyUnit CoordinatorsLegal Requirements – Data Protection / Section 251/ Secondary Use of DataQuality 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 babiesAlmost 60 years - longest running enquiry in the worldStrong 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 servicesROI included for 1st timeMDR is about understanding – not just counting – like air craft investigations
24 Impact of Maternal Deaths Maternal deaths – women who loose their lives prematurelyLive new-born deaths due to maternal causesExisting children loose their motherExisting children were in need of “care”
25 The maternal mortality or morbidity surveillance cycle 1. Identification ofcases2. Informationcollection5. Evaluation andrefinement3. Analysis of results4. Recommendationsfor action
26 UK Mortality Rates –Rise in 90s and early 2000 possibly due to improved case ascertainment
27 Maternal Death – UKSignificant 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 guidelines2006/08
29 Leading Cause Maternal Death 2006-08 Cardiac disease, pre existing medical conditionsDirect 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 servicesCommunications and referralsWomen with potentially serious medical conditions require immediate and appropriate multidisciplinary careClinical skills and trainingSpecialist clinical care: identifying and managing very sick womenSystolic hypertension requires treatmentGenital tract infection/sepsisSerious Incident Reporting and Maternal deathsPathology
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 & VSaving Mothers’ Lives , National launch - March 2011• Breathlessness• Headache• Anxiety and distresso Good mental health practice• Unexplained physical symptoms
32 MBRRACE Maternal death – highest priority for MBRRACE Includes late maternal death – up to 1 yearProcess of case ascertainment (estimate 85% deaths captured to date – complete information on around 50%)Recruitment of specialist advisors to assess case notes1st MBRRACE Maternal Mortality Report – December 2014Yearly reporting thereafter
33 Notification and case note collection Total cases known by yearEvaluated as completeCases with no notes of any kind200911491 (80%)10 (9%)201012638 (30%)10 (8%)2011106Not yet evaluated26 (25%)201213165 (50%)20135734 (60%)Total534
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 coincidentalYear 3: Pre-eclampsia and eclampsia, cardiac, early pregnancy
36 Perinatal and Infant Mortality MBRRACE ChangesInclusion of late fetal lossesNotification of neonatal death – 20 weeks or >500g where gestational age not availableExtension to 1 year 9previously 28 days)2013 confined to deaths in neonatal units only2014 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 timeCODAC (Cause of Death and Associated Conditions) – hierarchical tree of potential causes. Main cause of death is identified along with associated factors at three levels
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)
55 Uses of confidential enquiry data - Reasons Confidential enquiry is a qualitative approach: narrative-based medicineDescribes not just the ‘what’ but the ‘why’Detailed investigation of care against accepted standardsDoes not generate new information to change evidence-based practice, but does identify when current practice is not evidence-basedStories 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
59 Assessment of careAssessors are asked to assign cases to one of the following three categories after assessment:Good care; no improvements identified as being neededImprovements in care* identified which would have made no difference to outcomeImprovements 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 misconductDangerous lack of competencyBut not clear if incident has been reported to senior staffStandards in care that indicate a dysfunctional or dangerous department or organisation, or grossly inadequate service provision.
61 Sepsis Confidential Enquiry progress Topic Expert Group convenedKey standards identified32 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 6RCOG Green-top Guidelines 64b: Bacterial sepsis following pregnancy: Section 7Response and managementSurviving 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 pregnancyRCOG Green-top Guidelines 64b: Bacterial sepsis following pregnancyInvestigationsSurviving Sepsis Campaign Bundles: (http://www.survivingsepsis.org/bundles/Pages/default.aspx)Condition-specific guidanceBritish Thoracic Society guidelines for the management of community acquired pneumonia in adults: update 2009: Figure 8Critical 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 casesSample of 66 cases identified through a recent joint UKOSS and BAPS-CASS studyQualitative panel process guided by a care pathway developed by a Topic Expert Group (Dr Alyson Hunter, Royal Jubilee Maternity Hospital)Recruitment of panel membersPanels will be case specific – TOP, Stillbirths, Neonatal deaths, deaths post-surgery, survivors following surgeryDates for panels setTraining will be provided at the panelsUnits 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-mixThis 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 improvementLearn from othersChallenges and barriersIdentifying preventable deathsUnderstanding our dataImproving MDT mortality reviewService capacity – pathology, review
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 OfficeOffice based within Public Health Agency, Linenhall Street, BelfastHeather Reid, Regional Manager:Joanne Gluck, Clinical Research Midwife:Malcolm Buchanan, Administrator:Telephone number: