Public Health Wales

Maternity interventions 1000 Lives Plus

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

PAGE

1.Introduction

3

2. Aims

3

3. Research questions

3

4. Methods

4.1 Identifying existing and ongoing research

4

5. 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. 

1Introduction

The 1000 Lives Campaign was a national effort to improve the safety and quality of healthcare in Wales. 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. 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.

The safety of maternity services is a priority in a number of policy initiatives, for example, the National Service Framework (NSF) for maternity services, the NSF for children, young people and maternity services in Wales, Maternity Matters 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. In 2007-08, the Welsh Risk Pool paid out £28.4 million in respect of obstetric litigation claims.

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.

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

4Methods

4.1Identifying existing and ongoing research

Systematic searching: As per the information contained in the Public Health Wales Guide to Searching in Healthcare: the 4 steps , 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.

5Prioritisation 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. (Appendix 3)

· Existing Welsh initiatives

· Priorities transferability for Welsh NHS

· Primary/secondary care interface

· Strength of evidence

· Ability to measure – is there a baseline?

· Is the improvement feasible within a 1 year timeframe?

1 Results

The scoping search revealed several good quality reviews 8 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

6.1Option 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 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. The systems have now developed into critical care outreach services (CCOS) in the United Kingdom and rapid response teams (RRTs) in the United States. Concerns have been raised, both within the UK and internationally, at the evidence of effectiveness of RRTs/CCOS.

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 The systematic review of the literature published in 2006 included two RCTs, a single centre trial performed by Priestly et al. in England and Wales and the Australian multi-centre MERIT trial 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 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. 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.

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. 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).

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 ) 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. The use of a Modified Obstetric Early Warning Score (MEOWS) has been recommended in the CEMACH Report “Saving Mothers Lives” (2007). 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.

Guidelines for the use of MEOWS have been produced by the Royal Free Hospital. These guidelines suggest that all women entering an acute hospital should have their observations recorded on a MEOWS chart. The minimum frequency of observations as an in-patient is 12 hourly.

A comprehensive review of maternity services in Northern Ireland (NI) assessed the use of Physiological Early Warning System (PEWS) that had been implemented in the NI trusts. It was noted that there were some problems with the use of PEWS, but that the trusts had implemented training programmes and some were auditing outcomes.

Communication tools

Effective communication is central to promoting patient safety and reducing the number of serious clinical incidents. There was evidence to indicate that patient handovers in all healthcare settings are a vulnerable point during patient care. 12 It has been shown that approximately half of maternal deaths are associated with sub-standard care, with the main factors being poor communication and teamwork. Sabir et al. have described the problems that occurred in obstetric anaesthetic patients and problems across inter-professional boundaries have also been reported by the NPSA.

Standardised communication tools are considered to facilitate the transmission of critically important pieces of information. The Situation, Background, Assessment and Recommendation (SBAR) tool was developed for healthcare by Leonard and colleagues from Kaiser Permanente and has been used by maternity teams. SBAR is recommended both nationally and internationally by bodies such as the World Health Organisation, NPSA, IHI and the NHS Institute for Innovation and Improvement. In one health care setting, the incidence of harm to patients fell by 50% after implementing SBAR. There are other tools which are widely used, such as RSVP (Reason-Story- Vital Signs-Plan) which is in use at Luton and Dunstable Trust.

There was a lack of data on process measures designed specifically to evaluate changes in communication following implementation of SBAR. The Universities of Birmingham and Leicester are currently evaluating the use of EWSs and SBAR within the four 1st wave Safer Patient Initiative sites. Based on the evidence to date of poor uptake of protocol based care amongst doctors there appears little guarantee that utilisation of this communication tool will secure compliance and change in behaviour from the medical staff. The communication tool could be seen to introduce redundancy into the organisational system and the use of the tool could lead to devaluation of the knowledge of healthcare staff with implications for patient safety.

The SBAR tool has been adapted for the UK by the NHS Clinical Governance Support Team adding another dimension of sharing information. The adapted version CHAPS (Clinical picture, History, Assessment, Plan, Share information]) has been introduced in some UK maternity units.

Sepsis care bundles

Five years after the international Surviving Sepsis Campaign (SSC) care bundles were published. Care standards for the management of patients with severe sepsis are achieved in fewer than one in seven patients. The 2008 CEMACH report indicated that during the period 2006 – 2008, sepsis was the leading cause of direct maternal deaths, accounting for 26 direct deaths and a further 3 deaths classified as ‘Late Direct’. 7 The authors of the CEMACH report emphasised that the focus has to be on the early identification of patients with sepsis and delivery of a package of treatments within a few hours of the onset of the disease. Furthermore whilst maternal mortality is declining overall, maternal deaths due to sepsis have risen, particularly those associated with Gp A streptococcal infection.

Care bundles were developed by the IHI to help health care providers deliver consistently the best possible care for patients undergoing particular treatments with inherent risks. The IHI in collaboration with the SSC developed two ‘bundles’, or packages of care, for the treatment of those with severe sepsis:-

· The Severe Sepsis Resuscitation Bundle to complete in 6 hours following the recognition of severe sepsis 

· The Severe Sepsis Management Bundle to complete in 24 hours

Debate has surrounded many aspects of the SSC recommendations and bundles. In the UK, major challenges lie in placing central venous catheters, starting vasoactive infusions, and measuring central venous oxygen saturation (ScvO2) outside critical care. 44 This has led a number of clinicians worldwide to abandon the SSC Bundle and create a ‘simpler’ bundle, often targeting the first hour after presentation. The Survive SEPSIS organisation has introduced the concept of the Sepsis Six , six tasks to be completed by non-specialist staff within the first hour and the need for close and early liaison with critical care to complete Early Goal-Directed Therapy.

One prospective cohort study looked at the impact across a 500-bed acute general hospital of the SSC resuscitation bundle and the sepsis six intervention which is designed to facilitate delivery of the bundle. Process measures included compliance with the bundle and the sepsis six; the outcome measure was mortality at hospital discharge. The data from 567 patients were suitable for analysis. Compliance with the bundle increased from baseline with 84.6% of patients who received the sepsis six (n=220) achieving the resuscitation bundle compared with only 5.8% of the remaining 347 patients (p<0.001). Patients receiving the sepsis six (n=220) were less likely to die with mortality for the sepsis six (n=220) being 20.0% compared with 44.1% in those not receiving it (p<0.001). 5.9% (n=204) of patients receiving the resuscitation bundle died compared with 51% (p<0.001) of those not receiving it. Those receiving the sepsis six were much more likely to receive the full bundle. Those seen by the sepsis team had improved compliance with bundles and reduced mortality. The authors concluded that the results of the study support the SSC resuscitation bundle, and is suggestive of an association with reduced mortality although does not demonstrate causation.

An analysis of clinical trials of sepsis care bundles included 8 unblinded trials, one randomised and seven with historical controls. Sepsis bundles were associated with a significant increase in survival (OR 1.91; 95% CI 1.49-2.45; p < .0001). Bundle use was associated with consistent and significant improvement in survival and antibiotic use. Use of other bundle components changed heterogeneously across studies, making their impact on survival uncertain. However, this analysis should be interpreted cautiously as these studies were unblinded, and only one was randomised

Obstetric care bundles within the UK have not yet been widely implemented. A joint project aimed to develop and test two intrapartum care bundles building on the principles developed by the IHI. One for the care of women for whom electronic foetal monitoring is clinically indicated and the second for women with placenta praevia and a previous caesarean section. The selection of these topics was based on priorities identified by clinical experts and scoping work carried out by the NPSA. The preliminary results from an assessment of implementation of these 2 bundles suggested that a care bundle is valued much more if the benefits are linked directly to the area of responsibility of those completing it. This may be of relevance to the successful implementation of sepsis care bundles.

CONCLUSIONS – Option 1

The evidence (Level 1) was inconsistent with regard to the effectiveness of EWSs. National guidelines recommend the use of such scores. There was Level 3 and 4 evidence that a specific tool is required for use in maternity.

Communication tools are being used in many patient safety initiatives but high level evidence for their effectiveness was not found

There was evidence from unblinded trials and cohort studies on the effectiveness of sepsis care bundles in healthcare. Such bundles are yet to be evaluated in maternity care.

6.2Option 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

Induction of labour care pathway

There is a higher level of caesarean sections within Wales than in England and there are inconsistencies in the practices that trusts employ to prevent unnecessary caesareans. 8 All Welsh trusts exceed a 20% rate of caesareans, despite the World Health Organisation statement that there is no justification for caesarean rates higher than 15%. The Welsh Audit Office found inconsistencies in the practices that trusts employ to prevent unnecessary caesarean sections and poor and inconsistent use of data to inform performance. The National Sentinel Caesarean Section Audit reported in 2001 that Wales had the highest rate of caesarean sections out of all 11 participating countries. In 2001 the caesarean section rate in Wales was ≥ 24% and 26% in 2007-08. The typical caesarean rate in Wales is 26% compared with just below 24% in England.

The All Wales Clinical Pathway for Normal Labour (NLP) is a three part document, which records midwifery care from the onset of labour until birth, in a format designed to minimise writing unless the situation deviates from the norm. The document also functions as a protocol for practice, based on research evidence where this was available and best practice where this was not. The pathway is used solely by midwives.

Following an initial pilot, the pathway was introduced throughout Wales between 2002 and 2004. Evidence for its clinical effectiveness was sought by collecting data from 2 Welsh maternity units. An ethnographic approach was used to observe use of the NLP in real life settings and evaluate its implementation. Data were collected by means of semi participant observation, focus groups, and interviews. Participants (n = 56) included senior practitioners involved in creating the pathway (n = 4), midwives (n = 41), managers (n = 5), and doctors (n = 6). Data were analysed thematically. No data could be found on the effect of the NLP on rates of caesarean section after failed induction of labour. The results indicated that recently qualified midwives were more likely to view the pathway positively than those with more experience. Doctors were critical of the pathway, considering it to be exclusionary. Midwives and doctors thought that the NLP had increased inter-professional tensions. There was no evidence that it had increased the normal birth rate. The authors concluded that the results of the study raise questions about the appropriateness of clinical pathways and other standardised decision-making tools for the complexity of childbirth. One limitation of the study discussed by the authors is that data were only collected in two different maternity units, and thus may not be representative of the experiences of stakeholders in all Welsh maternity units.

Within England, a pilot study using a caesarean toolkit is underway in a number of regions aimed at a whole system approach to reducing the caesarean section rate. The Welsh Assembly Government decided to fund the mandatory implementation of this toolkit within all Welsh trusts. Every trust is expected to have implemented the toolkit by the end of the 2009-10 financial year. 8 The test sites in England observed a reduction in caesarean section rates in a majority of 19 trusts and increased VBAC rates. It was considered that if this programme was rolled out nationally and met all of its aims, the total saving to NHS England would be £76.8m. At a trust level this equates to £540,000 per Trust based on:

· £200,000 if caesarean section rates are reduced from 24% to 20%.

· £340,000 if length of stay is reduced from 4 to 2.5 days.

Implementation of vaginal birth after caesarean section (VBAC) clinics and improved access to support, advice and information.

Many women who have already had a caesarean section do not necessarily need to have another section when delivering their next baby. The Royal College of Obstetricians and Gynaecologists suggests that around three-quarters of women should be able to give birth vaginally after having a previous caesarean section, which is referred to as ‘Vaginal Birth After Caesarean’ (VBAC). A report from Wales indicated that not all trusts keep VBAC figures and only 7 trusts were able to provide data.8 Of these, the VBAC rate ranged from 17% to 37%. In around half of the participating trusts, staff felt that the rate of VBAC was appropriate. In the other half, at least 18 per cent of the staff in each trust felt that VBAC was not always offered when appropriate to do so. This lack of provision of the option for caesarean section is also confirmed internationally e.g. in the United States in the Listening to Mothers II survey 45% of participants would have liked the option of VBAC but were not given the option due in some part to the unwillingness of the care giver or hospital. Reluctance to allow VBAC is usually due to the fear of uterine rupture, but there is Level 2 evidence to indicate that prior caesarean section is not associated with uterine rupture.

Promoting normal birth is one of the High Impact Interventions for Nursing and Midwifery and the report indicates that VBAC clinics have been introduced into some English trusts with positive results.

In the present review there was a lack of high level evidence found on the effectiveness of VBAC clinics. VBAC clinics are in operation in hospitals in England and incentives have been offered in London to hospitals which reduce the caesarean section rate. The Mid Essex Hospital Trusts reported that since the introduction of VBAC clinics, there has been in increase in vaginal births after caesarean sections. In 2006, 60% of women attending the clinic had a vaginal birth; in 2007 this rose to 70%. 55 A more detailed report of the service from Worcestershire on the elective caesarean section audit indicated that prior to the clinic commencing, only 22% of women who had had a previous elective caesarean section wanted a vaginal birth; all had a caesarean section. In December 2005– December 2006 after implementation of a VBAC clinic, 66% of women who had had a previous elective caesarean section chose to have a vaginal birth. Of these 66% had a vaginal birth (52% normal birth) and 34% had an emergency caesarean section. Positive feedback regarding the VBAC clinic was received verbally from those women who attended the clinic, via the community midwives.

The Options for Assessment in early Labour (OPAL) study is a set of mixed methods studies aimed at investigating service provision for women in early labour in England and Wales. Part One (the telephone component) of the Welsh NLP was investigated as part of this project as it provided a specific example of a new innovation for women in early labour. In Wales, the researchers held focus group discussions with a sample of 21 midwives, and carried out computer assisted telephone interviews with 46 new mothers from six NHS trusts. Midwives generally agreed that Part One of the Pathway provided a standardised and straightforward way of documenting the advice given by midwives to low-risk women in early labour. Community midwives were less likely to use the form, partly because it was not always clear to them when they should use it, and partly because they would not always be able to deliver the form to the hospital for use when the woman next made contact there.

The Early Labour Support Assessment (ELSA) study is an RCT that investigated the effects of providing support to women at home in early labour, compared with normal hospital-based support for a range of outcomes including type of birth, women's interest in and experiences of care in labour, cost- effectiveness and the views of service providers. Six NHS trusts in England participated in the trial and the target sample size and high levels of data completion were achieved. No significant differences were detected between methods of care for caesarean section in labour, instrumental vaginal birth, labour duration, interventions and complications or for maternal or neonatal morbidity, breastfeeding or women’s pain six weeks after birth. Women evaluated home visiting positively and home visiting did not delay admission to the maternity unit. The majority of midwives and obstetricians were supportive of women being at home in early labour, but generally felt that more resources would be required to implement an early labour home visiting service. Overall there were no clear differences in resource use, associated costs or quality adjusted life-years (QALYs) between the 2 groups. From the NHS perspective, home-based care cost an additional £14 (95% CI -83.42 to 111.78) more than hospital-based care. It was associated with a small QALY gain of 0.0003061 (95% CI -0.0009975- 0.0016097), generating an incremental cost-effectiveness ratio (ICER) of £46,327.

An international RCT aimed to determine if a complex nursing and midwifery intervention in hospital labour assessment units would increase the likelihood of spontaneous vaginal birth and improve other maternal and neonatal outcomes. The rate of spontaneous vaginal birth was 64.0% (n=1597) in the structured care group and 61.3% (n=1533) in the usual care group (OR 1.12, 95% CI 0.96 to 1.27). Fewer women allocated to structured care (n=403, 19.5%) rated staff helpfulness as less than very helpful than those allocated to usual care (n=544, 26.4%); OR 0.67, 98.75% CI 0.50-0.85. Fewer women allocated to structured care (n=233, 11.3%) were disappointed with the amount of attention received from staff than those allocated to usual care (n=407, 19.7%); OR 0.51, 98.75% CI 0.32-0.70. The trial found that taking time to support women around the onset of labour had a positive effect on their experience of labour and confirms the results of an evaluation of the telephone component of the all Wales NLP which includes the offer of evidence based advice to women by telephone in early labour. 59

CONCLUSIONS – Option 2

Qualitative evidence suggests that implementation of the All Wales Clinical Pathway for Normal Labour has not been well received by some health care professionals.

A caesarean toolkit in use in England has been recommended for use in Wales by WAG. Preliminary evaluation in England indicates increased VBAC in a majority of the 19 trusts studied.

There was a lack of high level evidence on the effectiveness of VBAC clinics. VBAC clinics are in use in several hospitals in the UK and preliminary evaluations indicate that they do increase vaginal births after previous caesarean section.

Level 1 evidence from RCTs was found on providing support and information. Generally this evidence indicated that more intensive contact with health care staff and the provision of telephone support increased women’s satisfaction with maternity care; good evidence for the effect on vaginal birth was not found.

6.3Option 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

Reduced foetal movements

At present expert opinion states that there is no evidence that any absolute definition of reduced foetal movements is of greater value than maternal subjective perception of reduced foetal movements in the detection of intrauterine foetal death or foetal compromise. A 2007 Cochrane review (4 trials, 71,370 women) concluded that there is not enough evidence to influence practice on foetal movement monitoring. .

There are many guidelines for the management of decreased foetal movements but as yet none have complete international acceptance. The NICE antenatal care guideline states that routine formal foetal-movement counting should not be offered. For production of the NICE guidance one RCT was found that assessed the ability of the ‘count to ten’ method to reduce the prevalence of antenatal foetal death. The cluster RCT randomised 68,000 women to either routine formal foetal-movement counting or to standard care. It found that there was no decrease in perinatal mortality in the test group and this policy would have to be used by about 1250 women to prevent one unexplained death. One paper has examined the apparent divided opinion on the NICE recommendation for abandoning routine monitoring of foetal movements. The question faced by professionals in antenatal care is when to accept that foetal movements have been reduced for long enough to warrant intervention. The author reviewed a wider category of evidence than would have been included for the NICE recommendation. He concluded that the evidence supported the recommendation for abandonment of routine monitoring of foetal movements, but that if pregnant women have noticed a decrease in foetal movements for more than 12 hours then further assessment in hospital is indicated.

St Thomas’s Hospital research group is also looking at whether foetal movement is a useful measure of baby health. The group is currently recruiting 300 women who report reduced foetal movements to join a study that will test this theory. The women are assessed clinically, then a blood sample is taken and an ultrasound scan performed to measure foetal growth, the volume of liquor around the baby and blood flow through the umbilical cord. This will allow the evaluation of whether foetal movement monitoring combined with any of these investigations could decrease stillbirths. The group has also developed guidelines on foetal movements. The group’s research has shown that reduced foetal movement is a very reliable predictor of pregnancy complications and that previous practice in this area was chaotic and non-evidence-based.

Intrauterine growth restriction

A major focus of prenatal care is to determine whether a foetus is at risk for growth restriction and to identify the growth restricted foetus. Foetal growth is important because there is an inverse relationship between the foetal/neonatal weight percentile and adverse perinatal outcome, with the greatest risk at weights below the third percentile for gestational age. Intrauterine growth restriction (IUGR)/foetal growth restriction (FGR) is a condition where a baby's growth slows or ceases when in it is in the uterus. It is part of a wider group under the term small for gestational age (SGA) foetuses which includes foetuses that have failed to achieve their growth potential and foetuses that are constitutionally small.

INVESTIGATIONS

Numerous approaches to differentiate the foetus or infant with growth restriction from the small, but otherwise healthy, baby have been proposed. Clinical assessment is a reasonable screening tool for FGR in low risk pregnancies, as there is no high quality evidence that alternative approaches, such as routine ultrasound examination, improve outcome over clinical assessment alone. 13

Abdominal circumference

Most studies report that reduced abdominal circumference (AC) is the most sensitive single morphometric indicator of FGR. The AC measurement is the best single measurement to assess foetal growth because, where growth is restricted, the liver is usually affected. 14

Abdominal palpation 

Clinical assessment of foetal size by abdominal palpation does not perform well as a test for detecting FGR with sensitivities ranging from 30% to 50%. 13 Physical examination of the abdomen by inspection and palpation detects as little as 30% SGA foetuses. Therefore, if SGA is suspected, it is necessary to supplement abdominal palpation with ultrasound. Correct assessment of gestational age is essential and an ultrasound examination in the first trimester should be routine. 67

Ultrasound diagnosis

Clinical assessment alone is not adequate in pregnancies at high risk for FGR, given the low sensitivity. A variety of sonographic parameters has been used to screen for and diagnose FGR. A major limitation in interpreting the predictive value of ultrasound for diagnosing FGR and comparing predictive values derived from different studies is that these values depend upon the prevalence of FGR in the population studied. Thus, ultrasound results need to be interpreted in terms of pretest risk of FGR and take into account whether the subject population is at low, moderate, or high risk of foetal growth abnormality. 13

The use of Doppler ultrasonography to measure umbilical artery waveforms should be considered a part of foetal evaluation once IUGR is suspected or diagnosed. Modern techniques give very accurate information. One expert review indicates that the ultrasound criteria for IUGR include: 67

· An elevated ratio of femoral length to abdominal circumference

· An elevated ratio of head circumference (HC) to AC.

· Unexplained oligohydramnios

Measurement of symphysis-fundal distance

Measurement of the distance between the upper edge of the pubic symphysis and the top of the uterine fundus using a tape measure is a simple, inexpensive, and widespread procedure performed during antenatal care to detect foetuses that are growing poorly. The accuracy of fundal height measurements for screening for and diagnosis of FGR is controversial; a systematic review concluded there was not enough evidence to evaluate the use of this technique during antenatal care. 13 Observational studies using symphysis-fundal height measurements have reported a wide range of sensitivities: 28% to 86% of small foetuses were detected. 13 The NICE antenatal care guideline suggests that further research is needed to establish the diagnostic value and effectiveness of customised foetal growth charts to plot small for dates (SFD), particularly in relation to those pregnancies that appear small for gestational age. 64

The Map of Medicine care pathway for normal pregnancy recommends measurement of SFD.

MANAGEMENT

One review concluded that the optimal method of monitoring the foetus with suspected FGR has not been established. Periodic assessment, once or twice weekly from the age of viability, using the biophysical profile (BPP) and Doppler velocimetry is acceptable. The purpose of antenatal monitoring is to try to identify those foetuses that are at highest risk of in utero demise and neonatal morbidity, and thus may benefit from intervention by preterm delivery. 14 Ultrasound evaluation of foetal growth, foetal behaviour, amniotic fluid volume, and impedance to blood flow in foetal arterial and venous vessels form the cornerstone of evaluation of the foetal condition and decision making. Serial examinations should be performed with the frequency based upon the severity of findings and whether the examinations are being done to monitor foetal well-being (one to seven times per week) or foetal growth (every three to four weeks).

Medical interventions

There was a paucity of evidence from randomised trials that any specific antenatal treatment for the growth restricted foetus is beneficial. Numerous approaches have been used, including nutritional supplementation, plasma volume expansion, low-dose aspirin, heparin, bed rest, maternal oxygen therapy, and beta-mimetics/calcium channel blockers to improve blood flow to the placenta. None have consistently been shown to be of value. 14

Timing of delivery

The growth restricted foetus should be delivered if the risk of foetal death, as determined by antepartum monitoring tests, exceeds the risk of neonatal death. The difficulty in making this assessment was illustrated by the Growth Restriction Intervention Trial (GRIT), which randomly assigned pregnant women between 24 and 36 weeks to immediate (n = 296) or delayed (n = 291) delivery if their obstetrician was uncertain about when to intervene. Ninety percent of the pregnancies were complicated by clinical evidence of growth restriction and 40% had absent or reversed end diastolic umbilical artery flow. In the delayed delivery group, delivery occurred when the obstetrician was no longer uncertain about intervening (median delay 4.9 days). Deaths prior to hospital discharge were similar in both groups (29 deaths with immediate delivery and 27 deaths with delayed delivery). The immediate delivery group had fewer stillbirths (2 versus 9), but more neonatal and infant deaths (27 versus 18). Follow-up data at two years of age showed that the proportion of children with death or severe disability was similar for both groups (19% of immediate and 16% of delayed births). The small excess risk of mortality/severe disability in the immediate delivery group was primarily related to children randomised before 31 weeks of gestation. For this reason, the authors recommended delayed delivery in very preterm gestations if there was uncertainty about the need for intervention.

The NICE guideline for labour gives the following evidence statements :-

· For FGR identified between 24 and 36 weeks of gestation, there is insufficient evidence to determine whether immediate or delayed birth is beneficial. [Evidence Level 1+]

· For FGR at term, one small RCT reported that induction of labour (with PGE2 and amniotomy/intravenous oxytocin) and expectant management achieved similar maternal and foetal outcomes. [Evidence Level 1+]

· There is therefore little evidence of benefit for induction of labour in the presence of severe FGR. The guideline development group considered that labour in the presence of FGR may result in perinatal loss and that, in such cases, induction of labour should thus be avoided.

PREVENTION 

In subsequent pregnancies, prevention methods should be aimed at encouraging smoking cessation, reduction of alcohol intake and a balanced energy/protein supplementation in women with significant nutritional deficiencies. 14 Avoiding a short interpregnancy interval may also be beneficial. Although some randomised trials reported low-dose aspirin prophylaxis during pregnancy reduced the risk of recurrent FGR in women at high-risk (e.g. FGR in a previous pregnancy) larger randomised trials did not confirm significant risk reduction. 14 15

Aspirin may however be effective when FGR is related to preeclampsia. In a systematic review of 36 randomised trials including 23,638 women at high risk of developing preeclampsia, use of antiplatelet agents compared to placebo was associated with a 17% reduction in the risk of preeclampsia and a 10% reduction in the risk of SGA births (RR 0.90, 95% CI 0.83-0.98). Further study is urgently required.

CONCLUSIONS – Option 3

National evidence based guidelines do not recommend the use of routine monitoring of foetal movements.

Expert reviews were used to inform the detection and management of intrauterine growth restriction (IUGR). Whilst some interventions were supported by good quality evidence there was inconsistency in the evidence for some interventions. These issues need to be addressed by large multicentre studies employing consistent definitions, randomly assigned interventions, and with long-term follow-up.

The evidence presented in this review, some of which is international, for IUGR, requires expert analysis by healthcare staff involved in maternity care in Wales to verify its appropriateness and applicability.

6.4Option 4

Implementation of CMACE/RCOG Joint Guidance (2010) Management of Women with Obesity in Pregnancy

Obesity is associated with an increased risk of pregnancy related complications that affect both the mother and baby. In particular obese women are at risk of gestational diabetes, pre=eclampsia and hypertension. The 2010 paper from the Hyperglycaemia and Adverse Pregnancy Outcome (HAPO) study found that increased maternal obesity was strongly related to adverse pregnancy outcomes.  For the mother, it included a higher chance of having pre-eclampsia and delivery by caesarean section.  For the newborn, it resulted in having a higher birthweight, increased fat deposits and neonatal hyperinsulinaemia.  The authors concluded that the results demonstrate clearly for the first time that both maternal obesity and maternal hyperglycaemia have important and independent effects on pregnancy outcomes. The statistical methods used in this paper have however been subject to criticism.

A survey of maternity service provision for women with obesity found that 124 (44%) of maternity units did not have local guidelines for the care and management of women with obesity. CMACE and the RCOG have therefore produced a joint guideline on the management of obesity in pregnancy.

It is well known that successful implementation of guidelines is often difficult. A systematic review aimed to evaluate what strategies effectively implement clinical practice guidelines in obstetric care, and to identify barriers to change and facilitators in obstetrics. The review included 33 studies, nearly half of which had performed a prospective analysis of barriers to change and only 12 studies were RCTs. Inclusion/exclusion criteria for interventions, outcomes and participants were broad and ill-defined and the review was open to selection, publication and language bias. The authors concluded that implementation was improved by prospective identification of strategies to overcome barriers to change, recommending use of multifaceted interventions (with audit and feedback and reminders) led by local opinion leader.

The Maternity Evidence Group in the University of Birmingham are examining implementation of a set of maternity recommendations across the West Midlands trusts supplemented by qualitative work to ascertain what obstetricians and midwives believe influences implementation of selected NICE recommendations. The Group has also examined the recommendations for guideline implementation from some guideline organisations. According to NICE barriers to implementing national guidelines include:-

· lack of awareness and knowledge of evidence-based guidance

· acceptance and beliefs (e.g. perception that that the cost of implementing a guideline exceeds the benefit)

· lack of individual motivation (affected by both external and internal factors)

· inappropriate skills

· practical barriers such as lack of staff or resources

· external financial and political barriers at the organisational level (such as inappropriate reimbursements or financial regulations and constraints).

The most authoritative/reliable review of studies on guideline implementation is the Grimshaw health technology appraisal which showed that most interventions reporting dichotomous outcomes (such as proportions) found some improvement in care compared with controls:

• reminders had moderate effects (between 10 and 20% increase in effect)

• educational outreach (often alongside other interventions) could lead to modest improvements (between 5 and 10% increase in effect)

• educational materials and audit and feedback also had a modest effect.

• there were few comparisons of individual components of multifaceted interventions, multifaceted interventions being no more effective than single interventions.

CONCLUSIONS – Option 4

Obesity is known to affect the outcomes of pregnancy and guidelines have been produced on the management of obesity in pregnancy. Guideline implementation has been the subject of many systematic reviews. Many of these reviews have methodological problems.

There was limited systematic review evidence found on suitable methods for implementation of guidelines in obstetrics. One Level 2 study concluded that strategies to overcome barriers to change were required combined with the use of multifaceted interventions. No study was found on the implementation of obesity guidelines in pregnancy.

Research studies are examining the implementation of local guidelines in the UK.

6.5Option 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

Assessment of risk of venous thromboembolism (VTE) in early pregnancy for all pregnant women

Thromboembolic disease consistently represents the leading cause of direct maternal death in the UK 7 and measures aimed at prevention and a low threshold for investigation and treatment of suspected cases are essential. Pregnancy and the puerperium confer increased risk of VTE with the risk beginning in the first trimester and being greater postpartum than antenatally, particularly during the first postnatal week.

Increased risk is present from:-

· emergency caesarean section

· maternal age over 35

· weight over 80 kg

· pre-existing or family history of thrombophilia

· other medical conditions

· diabetes

· neurological disorders / other disorders reducing mobility

· multiple pregnancies

· preeclampsia

The Map of Medicine provides a pathway for VTE risk assessment and thromboprophylaxis during pregnancy and the puerperium. The pathways provide detailed evidence based information on the recommendations for risk assessment and prophylaxis.

Appropriate timely prophylactic treatment

There are UK and international guidelines for the management of VTE in pregnancy.

The NICE guideline has specific recommendations for VTE prophylaxis for pregnant women and up to 6 weeks post partum. These are:-

· consider offering pharmacological VTE prophylaxis with low molecular weight heparin (LMWH) (or UFH for patients with renal failure) to women who are pregnant or have given birth within the previous 6 weeks who are admitted to hospital but are not undergoing surgery, and who have one or more of the following risk factors:-

· expected to have significantly reduced mobility for 3 or more days

· active cancer or cancer treatment

· age over 35 years

· critical care admission

· dehydration

· excess blood loss or blood transfusion

· known thrombophilias

· obesity (pre-pregnancy or early pregnancy BMI over 30 kg/m2)

· one or more significant medical comorbidities (for example: heart disease; metabolic, endocrine or respiratory pathologies; acute infectious diseases; inflammatory conditions)

· personal history or a first-degree relative with a history of VTE

· pregnancy-related risk factor (such as ovarian hyperstimulation, hyperemesis gravidarum, multiple pregnancy or pre-eclampsia)

· varicose veins with phlebitis.

· consider offering combined VTE prophylaxis with mechanical methods and LMWH (or UFH for patients with renal failure) to women who are pregnant or have given birth within the previous 6 weeks who are undergoing surgery, including caesarean section.

· cffer mechanical and/or pharmacological VTE prophylaxis to women who are pregnant or have given birth within the previous 6 weeks only after assessing the risks and benefits and discussing these with the woman and with healthcare professionals who have knowledge of the proposed method of VTE prophylaxis during pregnancy and post partum. Plan when to start and stop pharmacological VTE prophylaxis to minimise the risk of bleeding.

As well as the NICE recommendations for VTE prophylaxis the recently published Cochrane review is relevant. Sixteen trials met the inclusion criteria but only 13 trials, involving 1774 women, examining a range of methods of thromboprophylaxis, contributed data for the outcomes of interest. Four of them compared methods of antenatal prophylaxis: LMWH versus UFH (2 studies), and heparin versus no treatment (2 studies). Eight studies assessed postnatal prophylaxis after caesarean section; one compared hydroxyethyl starch with UFH; 4 compared heparin with placebo; and the other 3 compared UFH with LMWH. One study examined prophylaxis in the postnatal period. The small number of statistically significant findings in this review was largely derived from trials which were not of high methodological quality. It was not possible to assess the effects of any of these interventions on most outcomes, and especially on rare outcomes such as death, thromboembolic disease and osteoporosis, because of small sample sizes and the small number of trials making the same comparisons. There was some evidence of side effects associated with thromboprophylaxis. The authors concluded that there is insufficient evidence on which to base recommendations for thromboprophylaxis during pregnancy and the early postnatal period. Large scale randomised trials of currently-used interventions should be conducted.

Appropriate support, advice and information

Requirements for support, advice and information are given in the NICE guidance and the RCOG guidance. 82 83 The guidance recommends that women at high risk of VTE in pregnancy, such as those with previous VTE, should be offered pre-pregnancy counselling and a prospective management plan for thromboprophylaxis in pregnancy. Those who become pregnant before receiving such counselling should be referred to a consultant obstetrician or trust-nominated expert in thrombosis in pregnancy early in pregnancy.

CONCLUSIONS – Option 5

Thromboembolism is the most important cause of maternal death and considerable research has investigated how to prevent such events.

There are evidence based pathways and guidelines for risk assessment for VTE and thromboprophylaxis during pregnancy and the puerperium.

A recent high quality Level 1 evidence source concluded that there was insufficient evidence to recommend any specific thromboprophylaxis during pregnancy and the early post-natal period.

2 Current Research

There is considerable research into improving the safety of obstetric and neonatal care. The 2 trials listed below are particularly relevant to the present questions.

Making Pregnancy Safer (MAPS) – the UK arm of the international SCOPE study: The SCOPE study (known as MAPS in the UK) is a large international study looking at how to predict and prevent the major diseases of late pregnancy: pre-eclampsia, preterm birth and foetal growth restriction. The project plans to recruit 10,000 pregnant women worldwide to test whether certain clinical and molecular markers (certain proteins, fats and small molecules in blood) can predict these complications. The Tommy’s centres in both Manchester and London are participating in this major study. 66

Randomized trial of timing of delivery in early preterm fetal growth restriction based on early and late fetal Doppler venous changes versus cardiotocography. Acronym TRUFFLE = Trial of Umbilical and Fetal Flow in Europe.

Optimal management of severe early foetal growth restriction is one of the greatest challenges in obstetrics. In the case of abnormal foetal monitoring obstetricians are often uncertain when to deliver these babies and how to balance between the complications of extreme preterm delivery and the risks of prolonged intrauterine exposure to malnutrition, hypoxia and antepartum death. The objective of this multi-centre randomised protocol is to determine which technique results in optimal timing of delivery of early preterm growth restricted infants. Twenty European perinatal centres are participating. This study will enable development of guidelines concerning timing of delivery in early preterm foetal growth restriction, which is of importance for all obstetric high care centres.

Appendix 1

EVIDENCE LEVELS AND QUALITY GRADING

(modified from NICE Guideline Methodology

Manual)

Level of Evidence

Type of Evidence

1++

High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias

1+

Well-conducted meta-analyses, systematic reviews of RCTs,or RCTs with a low risk of bias

1-

Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias

2++

High-quality systematic reviews of case control or cohort studies. High-quality case-control or cohort studies with a

very low risk of confounding, bias, or chance and a high probability that the relationship is causal

2+

Well-conducted case-control or cohort studies with a low risk of confounding, bias, or chance and a moderate

probability that the relationship is causal

2-

Case-control or cohort studies with a high risk of confounding bias, or chance and a significant risk that the relationship is not causal

3

Non-analytic studies (for example, case reports, case series)

4

Expert opinion, formal consensus

Quality grading

++ = good quality

+ = fair

+/- = fair to poor

- = poor

Appendix 2 Evidence table

Study

Population/

Setting

Intervention/aim

Outcomes

Results

Comments

Italics = reviewers comments

Design

Evidence level/

quality

Mackintosh N, Sandall J. Failure to rescue: problems and solutions. NIHR King's Patient Safety and Service Quality Centre 2008. (Evidence Level 3).

Maternity and acute care

Literature review on innovations to identify the deteriorating patient.

-

Comprehensive review indicating complexity of maternity care and evidence for methods for identifying problems and their causes.

Pragmatic review

3

++

Lee A, Bishop G, Hillman KM et al. The medical emergency team. Anaesthesia Intensive Care 1995; 23: 183-186.

Teaching hospital

Australia

Medical Emergency Team (MET)

Cardiopulmonary arrest

Cardiopulmonary resuscitation occurred in 148/522 calls(22%). Alerting the team resulted in CPR occurring in 253/522 (48%) calls.

First reported study of a MET

Case series

3

+

Esmonde L, McDonnell A, Ball C et al. Investigating the effectiveness of critical care outreach services: a systematic review. Intensive Care Medicine 2006; 32: 1713–1721.

Adults > 18 years

Secondary care critical care outreach service (CCOS).

Literature review to evaluate CCOS

-

There was insufficient evidence to support effectiveness of CCOS

Well conducted review.

2+

++

Priestley G, Watson W, Rashidian A et al. Introducing critical care outreach: a ward-randomised trial of phased introduction in a general hospital. Intensive Care Medicine 2004; 30: 1398–404.

District General Hospital

UK

CCOS interventions

In hospital mortality; length of stay (LOS)

Outreach intervention reduced mortality compared with control ( OR:0.52 (95% CI0.32-0.85). LOS results equivocal

No blinding

Pragmatic RCT

1_

+

Hillman K, Chen J, Cretikos M et al. Introduction of the medical emergency team (MET) system: a cluster-randomised controlled trial. Lancet 2005; 365: 2091–2097.

23 hospitals

Australia

Implementation of MET to reduce adverse events.

Cardiac arrest, unexpected death, or unplanned ICU admission

There was a similar incidence of the composite primary outcome in the control and MET hospitals (5.86 vs 5.31 per 1000 admissions, p=0.640), as well as of the individual secondary outcomes (cardiac arrests, 1.64 vs 1.31, p=0.736; unplanned ICU admissions, 4.68 vs 4.19, p=0.599; and unexpected deaths, 1.18 vs 1.06, p=0.752

The authors concluded that METs do not significantly affect the incidence of cardiac arrest, unplanned ICU admissions, or unexpected death.

Cluster RCT

1_

+

Winters BD; Pham JC; Hunt EA et al. Rapid response systems: a systematic review. Critical Care Medicine 2007; 35: 1238-43. (Evidence Level 2++)

Secondary care populations

Systematic review of studies on CCOS and EWSs

-

Authors concluded that there is weak evidence that rapid response teams reduce in hospital mortality

Review illustrates the bias in published studies

Meta-analysis

2++

Gao H, McDonnell A, Harrison DA et al. Systematic review and evaluation of physiological track and trigger warning systems for identifying at-risk patients on the ward. Intensive Care Medicine 2007; 33:667-679. .

31 acute hospitals

UK .

Systematic review of CCOS literature. Study looked at data sets from participating hospitals.

Composite of death, admission to critical care, ‘do not attempt resuscitation’ or cardiopulmonary resuscitation

No papers met the specified inclusion criteria. Fifteen datasets met pre-defined quality criteria. Sensitivities and positive predictive values were low, with median (quartiles) of 43.3 (25.4–69.2) and 36.7 (29.3–43.8), respectively.

Not strictly a cohort study. Review illustrates methodological problems with published papers.

Systematic review and cohort study

2++

+

Kause J, Smith G, Prytherch D et al. Intensive Care Society (UK); Australian and New Zealand Intensive Care Society Clinical Trials Group. A comparison of antecedents to cardiac arrests, deaths and emergency intensive care admissions in Australia and New Zealand, and the United Kingdom: the ACADEMIA study. Resuscitation 2004; 62: 275–282.

Acute hospitals

Australia, New Zealand (ANZ) and UK

Study of antecedents (physiological abnormalities) of serious adverse events such as cardiac arrest. Events over 3 days were logged in 90 hospitals.

Hospital deaths, cardiac arrests, and unanticipated ICU admissions. antecedents

638 primary events, there were 308 (48.3%) deaths, 141 (22.1%) cardiac arrests, and 189 (29.6%) unplanned ICU admissions. Sixty percent (383) of primary events had a total of 1032 documented. The most common antecedents were hypotension and a fall in Glasgow Coma Scale.

Case series

3

Subbe, CP, Kruger M, Rutherford, P et al. Validation of a modified Early Warning Score in medical admissions. Quarterly Journal Medicine 2001; 94, 521-526.

District General Hospital

North Wales

Use of MEWS in patients admitted to Medical Admissions Unit

Death, ICU & HDU admission, cardiac arrest, survival & hospital discharge at 60 days.

Scores of 5 were associated with death. MEWS were easy to use in the hospital setting after training.

Well designed and reported study.

Prospective cohort

2+

++

van Openraaij RHF. Predicting adverse obstetric outcome after early pregnancy events and complications: a review. Human Reproduction. Update 2009; 15: 409-421.

Pregnant women

Global

Evaluation from published literature of the impact of first trimester complications as predictors of adverse obstetric outcome.

Prediction of adverse events in pregnancy

Data from the literature indicated that there are parameters that can be used to predict adverse events during pregnancy. single previous miscarriage, the risk of very preterm delivery (VPTD) after >2 miscarriages, the risk of placenta praevia, premature preterm rupture of membranes, VPTD and LBW after recurrent miscarriage and the risk of VPTD after >2 terminations. in the ongoing pregnancy factors with an OR . 2.0 after complications in the index pregnancy are the risk of LBW and VLBW after a threatened miscarriage, the risk of pregnancy-induced hypertension, pre-eclampsia, placental abruption, PTD, SGA and low 5-min Apgar score after detection of an intrauterine haematoma, the risk of VPTD and IUGR after a crown-rump length discrepancy, the risk of VPTD, LBW and VLBW after a vanishing

twin phenomenon and the risk of PTD, LBW and low 5-min Apgar score in a pregnancy complicated by severe hyperemesis gravidarum

Very relevant to maternity. Limited search however

Literature review

2_

+

Swanton R, Al-Rawi S, Wee MYK. A national survey of obstetric early warning systems in the United Kingdom. International Journal Obstetric Anesthesia 2009:18: 253-257.

Consultant led obstetric anaesthetic units

UK

Survey to gauge opinions on use of MEWS in obstetrics

-

The results support the CEMACH recommendations for use of an obstetric EWS.

Emphasises the need for dedicated obstetric EWS

Postal survey

3

+

Borowitz SM, Waggoner-fountain LA, Bass EJ et al. Adequacy of information transferred at resident sign-out (in hospital handover of care): a prospective survey. Quality Safety Health Care, 2008;17: 6-10. (Evidence Level 3).

Acute paediatric ward

US

Characterisation of the effectiveness of the sign-out process between resident physicians on an acute care ward

In 49/158 surveys (31%), residents indicated that while on call incidents happened that they were not adequately prepared for. In 40/49 instances residents did not receive information during sign-out that would have been helpful, and in 33/40 the situation could have been anticipated and discussed during sign-out.

Survey

3

+

Sabir N, Yentis S M, Holdcroft A. A national survey of obstetric anaesthetic handovers. Anaesthesia,2006; 61: 376-380.

Consultant obstetric anaesthetists

UK

To record routine practice in their unit and individual opinion about handover procedures

-

76% of responding units had an allocated time for handover. 4% of units reported critical incidents following inadequate handovers in the past 12 months.

Survey

3

+

Daniels R, Nutbeam T, McNamara G et al. The sepsis six and the severe sepsis resuscitation bundle: a prospective cohort study. Emergency Medicine Journal doi:10.1136/emj.2010.095067. (Evidence Level 2-).

Acute general hospital

UK

Assessment of the delivery and impact of two interventions: the SSC resuscitation bundle and the sepsis six designed to aid implementation of the bundle.

Mortality at hospital discharge. Compliance with the bundle and the sepsis six;

Compliance of the bundle was greatly increased with the use of the sepsis six (85% vs 6%) The study supported use of the resuscitation bundle and the sepsis six.

Limitations of the study are addressed by the authors. Trial data is required.

Prospective cohort

2_

+

Barochia AV, Cui X, Vitberg D et al. Bundled care for septic care: an analysis of clinical trials. Critical Care Medicine 2010; 38: 668-678.

Literature review of clinical trials

Global

Assessment of the association between outcome and the utilisation of component therapies in studies of sepsis bundles.

-

8 unblinded trials, 1 randomised and 7 with historical controls, were identified. Improved survival was associated with bundle use.

Potential bias

2_

+

Hunter B. Implementing a national policy initiative to support normal birth: Lessons from the All Wales Clinical Pathway for Normal Labour. Journal of Midwifery and Women’s Health 2010; 5: 226-233.

Midwives, doctors, midwifery managers & mothers

Investigate results of policy initiative in Wales to promote safe birth

-

No evidence that implementation of pathway increased the normal birth rate. Some midwives and doctors

Only 2 maternity units were included. Illustrates difficulties of implementing care pathways

Qualitative study

3

++

Spiby H, Green JM, Hucknall C et al. Labouring to better effect: studies of services for women in early labour. Final report to the NIHR Service Delivery and Organisation Programme. SDO/64/2003. NCCSDO 2007.

Midwifery Unit heads in England

Midwives and mothers in Wales

To map early labour services and explore innovations.

To explore the perceptions of Part 1 (the telephone component) of the Welsh NLP among service users and providers.

To obtain health care providers’ views about using NHS Direct for early labour advice.

4 To inform the interpretation of the results of the ELSA trial

-

Midwives in Wales were generally positive about the pathway. Women’s views were mixed but generally satisfied with receipt of the leaflet and pleased with option of giving birth at home

Pivotal study on methods to improve early labour care and communication methods. Small study however, requires further research.

Qualitative study

2+

+

Spiby H. Improving care at the primary/secondary interface: a trial of community-based support in early labour. The ELSA trial. Report for the National Co-ordinating Centre for NHS Service Delivery and Organisation

R&D (NCCSDO) 2008.

Assessment of the impact of a policy of offering home visits by midwives to nulliparous women in early labour at term between 08.00- 21.00, compared with standard care and assessment in hospital.

Caesarean section rates. Instrumental vaginal delivery rates. Health & pain 6 weeks post partum

Home visits did not reduce the operative and instrumental births. The protective effect of home visiting against interventions during labour, was not achieved. no differences in

women’s pain at six weeks were identified and major perineal trauma.

Resource use and the estimated costs and outcomes in terms of QALYs were very similar between the two groups, and the

probability of home support being cost-effective ranged between 0.5-0.6.

The ELSA trial provides evidence of clinical, resource and financial implications

and the experiences of women, their families and midwives.

RCT

1-

++

Hodnett ED, Stremler R, Willan AR et al. Effect on birth outcomes of a formalised approach to care in hospital labour assessment units: international, randomised controlled trial Does a formalised approach to care in hospital labour assessment units affect birth outcomes. BMJ 2008;337: a1021.

Hospitals

North America & UK

Evaluation of usual nursing or midwife care compared with trained midwife nurse structured care

Spontaneous vaginal birth.

Intrapartum interventions, mothers views of care, indicators of maternal and foetal health

The rate of spontaneous vaginal birth was 64.0% (n=1597) in the structured care group and 61.3% (n=1533) in the usual care group (odds ratio 1.12, 95% CI 0.96 to 1.27). Maternal satisfaction was greater with structured care. No other results were stat. significant.

Good evidence that communication is important.

The effect on spontaneous vaginal birth requires further study.

Investigators took actions to minimise contamination. Blinding not possible.

Multicentre

RCT

Level 1+

+

Mangesi L, Hofmeyr GJ. Fetal movement counting for assessment of fetal wellbeing. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD004909. DOI: 10.1002/14651858.CD004909.pub2

. (Evidence Level

Pregnancy literature

Global

Literature review of papers that assess outcomes of pregnancy where fetal movement counting was done routinely, selectively or was not done at all; and to compare different methods of fetal movement counting.

Intrauterine foetal death.

Foetal compromise

Four studies, involving 71,370 women, were included; 68,654 in one cluster RCT trial. All 4 trials compared formal foetal movement counting

Author discusses the need for RCTs comparing foetal counting with no foetal counting

Systematic review

1++

+

Thornton JG, Hornbuckle J, Vail et al. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial. Lancet 2004; 364: 513. (Evidence Level 1-)

HAPO Study Comparative research group. Hyperglycaemia and Adverse Pregnancy Outcome (HAPO) study: associations with maternal body mass index. British Journal Obstetrics Gynaecology 2010; 117: 575-584.

15 maternity centres in 9 countries

Global

Determination of whether higher maternal BMI independent of maternal glycaemia is associated with pregnancy outcomes

Birth weight>90th percentile. Primary caesarean section. Neonatal hypoglycaemia. Cord serum C-peptide >90th percentile.

In the 23,316 blinded participants Higher BMI was associated with increased frequency of birth weight >90th percentile, caesarean section.

Statistical methods are questionable. Using weights recorded in the third trimester as a surrogate for pre-pregnancy BMI leaves it open to substantial bias.

Cohort

3

+/-

Chaillet, N., Dube, E., Dugas, M. et al. Evidence-based strategies for implementing guidelines in obstetrics: a systematic review. Obstetrics Gynecology, 2006; 108: 1234-1245.

Obstetric guidelines

Review of literature on implementation methods for obstetric guidelines.

Successful implementation

33 studies included. 12/33 were RCTs. Implementation was most effective with methods aimed at overcoming barriers to change.

Only reference specific to implementation of obstetric guidelines. Does not provide evidence on effective methods

Systematic review

2-

+

Grimshaw, JM, Thomas R E, MacLennan G et al. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technology Assessment 2004, 8. (Evidence Level 2+)

Guideline development & implementation literature

Review of literature

Successful implementation

235 studies reporting 309 comparisons were included. The authors concluded that the evidence base was not sufficient to recommend any specific methods

Systematic review

2-

++

Tooher R, Gates S, Dowswell T, Davis L-J. Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period. Cochrane Database of Systematic Reviews 2010, Issue 5. Art. No.: CD001689. DOI: 10.1002/14651858.CD001689.pub2.

Obstetric literature

Determination of the effects of thromboprophylaxis in women who are pregnant or have recently delivered and are at increased risk of TED on the incidence of venous TED and side effects of treatment.

Occurrence of VTE. Mortality. Osteoporisis.

13 trials were included. Statistically significant results were only found in trials of poor quality. No conclusions could be made

Systematic review

1++.

Appendix 3

CRITERIA FOR SELECTION OF MATERNITY INTERVENTIONS

INTERVENTION

TRANSFERABILITY FOR WELSH NHS

PRIMARY/SECONDARY CARE INTERFACE

EXISTING WELSH INITIATIVES/ PRIORITIES

STRENGTH OF EVIDENCE

ACHIEVABLE IN 1 YEAR

ABILITY TO MEASURE – is there a baseline?

Recognition, communication and treatment of acutely ill women by implementation of:

Early warning systems (EWSs)

Communication tool SBAR

Sepsis care

bundles

Yes

Yes, but more applicable to secondary care

Yes

EWSs and communication tools are in use in Wales.

Sepsis care bundles are in use in Wales. No information was found on their use in maternity units in Wales,

Large amount of Level 3 (observational) evidence.

The evidence for EWSs is controversial. NICE guidelines recommend.

Level 1 and 2 evidence with some methodological issues for sepsis care bundles

?

Yes

Require figures for baseline. WAG maternity statistics do not give information

Optimising caesarean section rate by implementing:

Induction of labour care pathway

Vaginal birth after c/s (VBAC)

clinics

Yes

Yes

No

Yes if VBAC clinics held in the community

Yes

Yes

Level 3

Level 3/4

Yes/?

Yes

Yes

Figures are available for caesarean section rate in Wales.

Standardising the detection and management of IUGR

Implement standard management of reduced foetal movements and the detection and management of IUGR

Yes

Yes

Yes

Good quality Level 1 and Level 2 evidence on some interventions for IUGR and national guidelines. A lot of the evidence is international and requires expert assessment for generalisability to UK.

Yes/No/?

Development of local /national consensus on evidence based recommendations will take time.

Yes/?

WAG statistics available on preterm birth and foetal stress

Implementation of CMACE/RCOG Joint Guidance (2010) Management of Women with Obesity in Pregnancy

Yes

Yes

?

No evidence available on implementation of the recent obesity guidelines.

Level 2 evidence on methods for guideline implementation

No/?

?

Difficult to measure in short term

Reducing deaths and harm from thrombosis and embolism during pregnancy and the puerperium

Assessment of risk of VTE in early pregnancy for all pregnant women

Appropriate timely prophylactic treatment with appropriate support, advice and information

Yes

Yes

No for maternity care. There are VTE initiatives in the 1000 Lives Campaign

Level 1 and Level 2 evidence and national guidelines.

Recent Cochrane review concludes there is a lack of evidence for VTE prophylaxis. National guideline recommendations for information and support.

Yes/?

Yes.

Figures are required for baseline

� Specify whether measures are outcome or process

� This Table needs input from Expert Group and PHW Observatory

� Relevance now WAG guidance to implement caesarean toolkit?

8.References

� 1000 Lives. Available at: � HYPERLINK "http://www.wales.nhs.uk/sites3/home.cfm?orgid=781" ��http://www.wales.nhs.uk/sites3/home.cfm?orgid=781�. [Accessed 29th November 2010].

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� 1000 Lives Plus. Available at: � HYPERLINK "http://www.wales.nhs.uk/sites3/home.cfm?orgid=781" ��http://www.wales.nhs.uk/sites3/home.cfm?orgid=781�. [Accessed 29th November 2010].

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[Accessed 20th November 2010].

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(Evidence Level 4)

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� Morgan R M, Williams F, Wright M M. An early warning scoring system for detecting developing critical illness. Clin Intensive Care 1997; 8 : 100. (Evidence Level 4)

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� Lappen JR, Keene M, Lore M et al. Existing models fail to predict sepsis in an obstetric population with intrauterine infection. Am J Obstey Gynecol 2010: � INCLUDEPICTURE "http://www.sciencedirect.com/scidirimg/clear.gif" \* MERGEFORMATINET ���� HYPERLINK "http://dx.doi.org/10.1016/j.ajog.2010.07.040" \t "doilink" �doi:10.1016/j.ajog.2010.07.040�. (Evidence Level 4).

� Lewis G. The Confidential Enquiry into Maternal and Child Health (CEMACH). Saving mothers' lives: