Maternity interventions for the 1000 Lives Plus programme: a rapid review of the evidence
Author: Dr Mary Webb, Public Health Practitioner
Date: 21 November 2010 / Version: 1
Publication/ Distribution: Dr A Wilson, Director 1000 Lives Plus
Purpose and Summary of Document: Options for maternity interventions have been proposed for the 1000 Lives Plus Programme. The present document reports on a rapid review of the evidence for the effectiveness of five interventions. These are methods for:-
· Recognition, communication and treatment of acutely ill women.
· Optimising caesarean section rate.
· Standardising the detection and management of intrauterine growth restriction (IUGR).
· Implementation of guidance for management of women with obesity in pregnancy.
· Reducing deaths and harm from thrombosis and embolism during pregnancy and the puerperium.
The levels of evidence found by the searches varied for the interventions, but when combined with other criteria suggested for prioritisation of the interventions and subsequent expert advice may provide an indication of which options should be implemented initially into the 1000 Lives Plus programme.
Work Plan reference: HS39
Contents
1.Introduction / 3
2. Aims / 3
3. Research questions / 3
4. Methods
4.1 Identifying existing and ongoing research / 45. Prioritisation for Wales / 5
6. Results / 6
6.1 Option 1 / 6
Early warning systems / 6
Communication tools / 8
Sepsis care bundles / 9
6.2 Option 2 / 11
Induction of labour care pathway / 11
Implementation of vaginal birth after caesarean section (VBAC) clinics and improved access to support, advice and information. / 13
6.3 Option 3 / 15
Reduced foetal movements / 15
Intrauterine growth restriction / 16
6.4 Option 4 / 20
Implementation of CMACE/RCOG Joint Guidance (2010) Management of Women with Obesity in Pregnancy / 20
6.5 Option 5 / 22
Assessment of risk of venous thromboembolism (VTE) in early pregnancy for all pregnant women / 22
Appropriate timely prophylactic treatment / 23
Appropriate support, advice and information / 24
7. Current Research / 25
8. References / 26
Appendices / 33
© 2010 Public Health Wales NHS Trust.
Material contained in this document may be reproduced without prior permission provided it is done so accurately and is not used in a misleading context.
Acknowledgement to Public Health Wales NHS Trust to be stated.
1 Introduction
The 1000 Lives Campaign was a national effort to improve the safety and quality of healthcare in Wales. [1] The campaign was based on the 100,000 Lives Campaign, created by the Institute for Health Improvement (IHI) in the United States, which included 12 healthcare interventions. [2] Every health board and NHS trust in Wales took part and has been implementing agreed interventions, monitoring their impact and reporting on progress. The two year patient safety initiative estimated that 852 additional lives have been saved in its first eighteen months and more than 29,000 episodes of harm have been averted in its first twelve months. 1 The Campaign was succeeded in May 2010 by 1000 Lives Plus, a five-year programme which will carry on and extend patient safety and the improvement in the quality of Welsh healthcare. [3]
The safety of maternity services is a priority in a number of policy initiatives, for example, the National Service Framework (NSF) for maternity services,[4] the NSF for children, young people and maternity services in Wales, [5] Maternity Matters [6] and by a range of organisations such as the National Institute for Health and Clinical Excellence (NICE), the Wales Audit Office and the National Patient Safety Agency (NPSA) with under its aegis confidential enquiries into maternal and perinatal health.
The latest Confidential Enquiry into Maternal and Child Health (CEMACH) report indicates that the incidence of intrapartum deaths has not changed significantly since 2000. [7] In 2007-08, the Welsh Risk Pool paid out £28.4 million in respect of obstetric litigation claims. [8]
Patient safety interventions for maternity services have therefore been proposed for the 1000 Lives Plus programme and Public Health Wales were asked to review the evidence for these.
2 Aims
Rapid review of the evidence for the five options for interventions for maternity care (listed in Section 3)
3 Research questions
The proposed five options were converted into questions using the Patient, Intervention, Comparison and Outcome (PICO) format for literature searching purposes. [9]
Option 1
Recognition, communication and treatment of acutely ill women by implementation of:-
· Early warning systems
· Communication SBAR tool
· Sepsis care bundles
Option 2
Optimising caesarean section rate by implementing:-
· Induction of labour care pathway
· Vaginal birth after caesarean section (VBAC) clinics and improved access to support, advice and information
Option 3
Standardising the detection and management of intrauterine growth restriction (IUGR)
· Implement standard management of reduced foetal movements and the detection and management of IUGR
Option 4
Implementation of CMACE/RCOG Joint Guidance (2010) Management of Women with Obesity in Pregnancy
Option 5
Reducing deaths and harm from thrombosis and embolism during pregnancy and the puerperium
· Assessment of risk of venous thromboembolism (VTE) in early pregnancy for all pregnant women
· Appropriate timely prophylactic treatment
· Appropriate support, advice and information
4 Methods
4.1 Identifying existing and ongoing research
Systematic searching: As per the information contained in the Public Health Wales Guide to Searching in Healthcare: the 4 steps [10], a scoping search was initially performed to identify major papers on published evidence and refine the final search strategy. For the present overview, search terms contained in search strategies were used from published reviews and they were kept broad to maximise retrieval of references. Details of the search strategies may be obtained from the author. The type of literature on maternity care necessitated the use of a pragmatic approach to searching for evidence in order to achieve production of the review, within the short timescales for delivery. It is clear that there had to be a balance between timeliness and rigour. High quality evidence and systematic reviews, meta-analyses, randomised controlled trials (RCTs), health technology assessments and clinical guidelines were identified first.
High level searching: It is well known that the classical databases for medical literature, such as Medline, do not adequately index all relevant literature. The reviewer used previously described validated methods that involved the use of meta-search engines and other databases for ‘high level’ searching to quickly identify relevant evidence.
For critical appraisal, the tables recommended for use in the National Institute for Health and Clinical Excellence Guideline Development Methods manual were modified to accept the type of studies identified for vascular risk screening interventions. The quality of the evidence was graded using the NICE hierarchy of evidence and the quality checklists. Evidence was rejected if graded as poor quality, apart from where it was of Level 1 type (see Appendix 1 for explanation of evidence grading system) and was highly relevant to the question.
The data relevant to the research question was entered into an evidence table (Appendix 2). Due to practical limitations a single reviewer performed the final selection, critical appraisal and data extraction. Every effort was made to minimise reviewer bias. However it should be emphasised that the review is not a systematic review of primary studies.
5 Prioritisation for Wales
The interventions suggested by the Maternity Mini-Collaborative Group for the 1000 Lives Plus programme were assessed using some of the criteria employed by the National Public Health Service (NPHS) for the initial phase of the 1,000 Lives Campaign in Wales. [11] (Appendix 3)
· Existing Welsh initiatives
· Priorities transferability for Welsh NHS
· Primary/secondary care interface
· Strength of evidence
· Ability to measure[1] – is there a baseline?
· Is the improvement feasible within a 1 year timeframe?
6 Results
The scoping search revealed several good quality reviews 8 [12] [13] [14] that were relevant to the questions and these were used to inform the present document, supplemented with other evidence, where available.
As with previous CEMACH enquiries the commonest cause of direct maternal death was thromboembolism. There was a slight increase in deaths from sepsis and pre-eclampsia, but deaths from haemorrhage, anaesthesia and uterine trauma had decreased compared with past figures. 7
6.1 Option 1
Recognition, communication and treatment of acutely ill women by implementation of:-
· Early warning systems
· Communication tool SBAR (Situation, Background, Assessment and Recommendation)
· Sepsis care bundles
Early warning systems
The National Confidential Enquiry into Patient Outcome and Death [15] identified the prime causes of the substandard care of the acutely unwell in hospital as:-
· delayed recognition
· implementation of inappropriate therapy that subsequently culminated in a late referral
Medical emergency teams (METs) and critical care outreach services were founded in the 1990s with the concept of METs using the well-recognised principle that early recognition and aggressive intervention improves outcome from critical illness. [16] The systems have now developed into critical care outreach services (CCOS) in the United Kingdom and rapid response teams (RRTs) in the United States. [17] [18] Concerns have been raised, both within the UK and internationally, at the evidence of effectiveness of RRTs/CCOS. [19]
Outreach services may cover a range of activities and appraisal of the evidence for their effectiveness is hindered by the lack of service standardisation globally. The evidence for the effectiveness of critical care outreach services and the controversies surrounding the issue was reviewed by the NPHS in 2007. 11 The limited available evidence on the effectiveness of CCOS has been highlighted by other researchers in the field. 19 [20] [21] The systematic review of the literature published in 2006 [22] included two RCTs, a single centre trial performed by Priestly et al. in England and Wales [23] and the Australian multi-centre MERIT trial [24] and 21 observational studies of variable quality. The MERIT study found no difference between the intervention group and the control group for a composite outcome, which comprised the incidence of cardiac arrest, unplanned intensive care unit (ICU) admission (without not for resuscitation [NFR]) and unexpected death (without NFR). For mortality rates the findings were different in the two studies in that the Priestley study found a significant reduction in mortality (but failed to report do-not-resuscitate orders), whereas the MERIT study found no difference between the two arms of the study for this outcome. The authors of the systematic review concluded that there is insufficient good quality evidence to confirm the effectiveness of CCOS on patient or service outcomes, but the evidence has not demonstrated that such services are ineffective.
Another systematic review published in 2007 [25] conducted a meta-analysis of included studies and described the potential for bias of the included studies. Lack of comparability between controls and study groups, unclear outcomes and non-adjustment for demographic differences introduce bias and none of the 8 included studies had a control group that was clearly comparable with the intervention group. The authors concluded that there is weak evidence that RRTs are associated with a reduction in hospital mortality and cardiac arrest rates, but problems with quality and heterogeneity of the original studies and the wide confidence intervals limit the conclusion that RRTs are effective interventions. The National Institute for Health and Clinical Excellence was commissioned to produce a guideline for best practice in the treatment of acutely ill patients in hospital. [26] NICE was unable to recommend outreach services due to a lack of supportive evidence, but recommended the use of early warning scoring systems (EWSs). It was unable to identify a particular system or cut off points due to the lack of evidence of accuracy for these scores in clinical practice. [27]
Early warning systems rely on observations of the physiological status of the patient and the choice of physiological variables is based on studies of the relation between physiological abnormalities and mortality. [28] [29] If the total score exceeds a predefined cut-off this triggers immediate actions, including calls for experienced senior clinical advice and critical care outreach assessment. Although there is little evidence of the reliability and validity of these physiological variables, track and trigger EWSs have been introduced globally and are widely used. There are various EWSs in use in secondary care in Wales, but evaluative studies of these interventions are not readily available. In a well designed and reported prospective cohort study performed in North Wales scores of 5 or more for an EWS were associated with increased risk of death (odds ratio [OR] 5.4, 95% confidence interval [CI] 2.8–10.7), ICU admission (OR 10.9, 95% CI 2.2–55.6) and high dependency unit admission (OR 3.3, 95% CI 1.2–9.2). [30]
Obstetric patients are at risk for pregnancy-related and medical/surgical complications. Literature reviews have indicated the impact of early pregnancy events and complications as predictors of adverse obstetric outcome. (see e.g. van Oppenraaij [31] ) The timely identification of clinical deterioration and referral for appropriate care are key issues in the management of women who become critically ill during pregnancy, labour and the postpartum period.
Various studies have indicated that early warning scoring systems such as the Medical Early Warning Score (MEWS) or Systemic Inflammatory Response Syndrome Score (SIRS) do not identify accurately patients who are at risk for ICU transfer, sepsis, or death among pregnant women with intrauterine infection and should not be used in an obstetric setting. [32] The use of a Modified Obstetric Early Warning Score (MEOWS) has been recommended in the CEMACH Report “Saving Mothers Lives” (2007). [33] The MEOWS that is in use has been provided by CEMACH until national pilots are completed to determine the most appropriate system to use nationally.
A survey of all UK consultant led obstetric anaesthetic units in 2007 to assess the value and use of EWSs indicated that of the 71% who replied, 89% thought it would be possible to introduce a standardised national obstetric EWS. Ninety six percent of hospitals used a non-obstetric EWS, only 23% of respondents thought that this was relevant to obstetric physiology and disease. The authors of the report have devised and implemented locally an obstetric EWS that is used on women identified as high risk pregnancies. A Joint Standing Committee between the Royal College of Obstetricians and Gynaecologists and the Obstetric Anaesthetists Association has been set up to gain information about the use of obstetric EWSs in the UK. [34]