North Staffordshire Hospital NHS Trust, Ward 59, Maternity Unit,
Newcastle Road, Stoke-on-Trent, ST4 6QG
1
Derby City Hospital, Uttoxeter Road, Derby DE3 3NE
2
Leicester General Hospital, Gwendolin Road, Leicester LE5 4PW, UK
Correspondence to: Claire Rigby, Clinical Governance Support Officer E-mail: c.rigby{at}keele.ac.uk
| SUMMARY |
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540 babies (4.3%) had low Apgar scores, and neither the percentage nor gestational age differed significantly between audit periods. In the baseline audit, care was judged suboptimal (grade II/III) in 14 (74%) of 19 cases, and in the next four periods it was 23%, 27%, 27% and 32%. In the latest audit period, after further educational interventions, it was 9%. Many of the failures to recognize or act on abnormal events were related to CTG interpretation. After the interventions there was a significant increase in cord blood pH measurement. There were no differences between audit periods in the proportion of babies with cord pH <7.2.
These results indicate that substantial improvements in quality of intrapartum care can be achieved by a programme of clinical risk management.
| INTRODUCTION |
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Although intrapartum death is undoubtedly a calamity, brain damage has more far-reaching consequences for the family and for the health professions5. The evidence linking brain damage to intrapartum care remains uncertain5,6,7,8 but this has become the dominant litigation theme internationally. Where liability and causation are both conceded, awards in court to a litigant may be in excess of £3 million. Currently obstetric cases are costing the National Health Service (NHS) £160-200 million/year, constituting 60% of litigation pay-outs (Towns D, personal communication). In terms of contingent liability, the figures facing the NHS are even greater. This has been estimated at nearly £3 billion, against the total NHS annual budget of £37 billion9. Although the scoring system used by CESDI assessors has not been formally applied to assessments of care of brain-damaged babies, it is clearly relevant given that suboptimal care is very likely to be considered indefensible in court.
Because both intrapartum death and intrapartum brain injury are rare events, an alternative outcome is required for monitoring quality of care. One approach is to identify near-miss cases10. Currently no single outcome measure can identify such a group6. However, the Apgar score is a convenient tool used by all maternity professional groups as a broad measure of immediate fetal wellbeing, and a very low Apgar score is known to be associated with an increased risk of cerebral palsy6. Although most babies born with low Apgar scores have good outcomes, they constitute a convenient group in which to establish regular monitoring of quality of care in labour11. In 1994, we had our first multidisciplinary democratic prioritization audit planning day (ASQUAM: Achieving Sustainable Quality in Maternity). This process, described elsewhere12, resulted in the choice of ten topics per year. Improving the quality of intrapartum fetal care (and therefore minimizing liability) was one of the topics chosen for audit at this first meeting. Subsequently, a further audit standard in relation to measuring cord gases in all at risk infants was included. If normal cord gas results can be presented, the suggestion of a damaging intrapartum hypoxic event is more easily countered6. Very few centres in the UK systematically undertake cord-blood sampling8.
| METHODS |
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5 at 1 minute
7 at 5
minutes but the 1-minute cut-off was amended to
4 from audit period 3
(December 1997) onwards. Other risk criteria could equally have been chosen to
identify a group for closer audit, such as low birthweight or preterm
gestation. We wished to identify the main areas of suboptimal care and the
level of person responsible. In those cases which might have been
medicolegally indefensible (CESDI grade II/III), we wished to categorize the
main shortcoming in care and note the level at which deficiencies occurred, so
as to allow educational feedback to medical and midwifery staff. We also
wished to examine in more detail the nature of CTG problems in CESDI grade
II/III cases and the rate of cord gas analysis in this cohort. The audit team
consisted of the clinical governance support officer (CR), a senior labour
ward midwifery sister (MM), an obstetric senior registrar with a perinatal
interest (RH, SH and PY) and a senior lecturer in perinatology (RJ). Our audit
standard was that No babies born with low Apgar scores should have had
suboptimal (CESDI grade II/III) care.
Audit method
The audit was a critical retrospective analysis of case notes by the team
and consensus between authors on whether there was evidence of suboptimal
care. Certain cases (usually difficult or controversial) were chosen for
discussion in greater detail at the low Apgar meeting. The
purpose of the meeting was not to lay blame but to learn jointly from
mistakes13. Details
that could have identified patients and staff were withheld to allow
objectivity. Final CESDI grading was agreed democratically, along with
judgments about principal areas of deficiency and the level at which deficient
care occurred (in some cases more than one level):
The baseline audit was undertaken in October 1994. The initial interventions thereafter consisted of an open feedback meeting and reinforcement of current labour ward guidance on CTG interpretation and on communication. A follow-up audit was undertaken in October and November 1995. Thereafter, the audit consisted of a series of interventions linked to cyclical review.
Long-term interventions and cyclical audit
Local guidelines
Recommendations from the third CESDI report, findings from the Cochrane
Database of Systematic
Reviews14 and
evidence from published observational work were incorporated in local
guidelines. The guidelines include examples of abnormal CTGs from the
Crimson File (a collection of case studies, mainly of
intrapartum death, drawn from the West Midlands
region)15. These
guidelines were available in full on the labour ward and on the antenatal and
postnatal wards as well as in the antenatal clinics, and in the midwifery and
medical libraries. A shortened version of the guideline was included in the
hospital pocket handbook used by all staff on labour ward.
Regular monthly audit
This began at the end of November 1995. All case records of babies who had
low Apgar scores 2 months previously were reviewed.
Feedback meetings
Regular low-Apgar meetings began in November 1995. All staff,
obstetricians, anaesthetists, paediatricians and hospital and community
midwives were invited. The cases with low Apgar scores from 2 months
previously were discussed with an increased focus on cases where CESDI grading
was considered to be II/III. However, we took pains to discuss not only cases
where care might have been poor but also those where care was of a high
standard, enabling some positive feedback. The sessions were also used for
continuing CTG education, as an adjunct to the CTG training programme
introduced in our unit. Where serious deficiencies in care were identified,
individual educational feedback was sensitively undertaken before the meeting,
enabling the individuals to gain maximum benefit from the meeting.
Teaching programme
RH initiated the first six-session CTG training course. These have been
repeated on several occasions, the format having evolved over the intervening
4 years, currently taking two half days every six months (for both midwives
and doctors). To date, about 130 midwives have attended for training, with
nearly 100 of them attending all sessions; however, only a minority of doctors
have participated.
Feedback from conference presentations
Presentations of the low-Apgar audit made at national and international
conferences were given locally as well. Posters shown at these conferences
were also displayed in various locations within the maternity block.
Statistical methods
To assess the change in distribution of different outcome variables over
the six audit periods we used the KruskalWallis test. Armitage's trend
test16 was also
used, for example, to compare grade 0 with grades I/II/III and grade III with
grades II/I/0 over the six periods. The software was StatXac Turbo (CYTEL),
Cambridge, Massachusetts.
| RESULTS |
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12=0.0012, P=0.97); nor did the proportion
of low-Apgar cases differ significantly between audits.
Of the 19 cases in the baseline audit period, 14 (74%) had grade II/III
suboptimal care (Table 1).
Following the initial interventions, the proportions of grade II/III cases
fell significantly and this improvement was sustained over the next four
periods of the audit programme (23%, 27%, and 32%). After CTG training was
made compulsory for all staff involved in intrapartum
care17, the
proportion of II/III cases fell to 9.25%. The differences seen in overall
distribution of CESDI scores were highly significant according to the
KruskalWallis statistic (based on
52=46.23).
The trend test comparing grade 0 with I/II/III was also significant (trend
12=18.45, P<0.001), as was the trend
test comparing grade III with II/I/0. However, during the four periods, the
proportion of babies requiring admission to the neonatal unit did not change
significantly, nor did the number of babies with a cord pH <7.2 change over
the audit periods. The proportion of cases where cord pH was taken and
documented did increase significantly over the period (trend
12=7.76, P=0.0053).
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The main areas of suboptimal care and the levels of responsibility are shown in Table 2. The scope for improvement is in the first two itemsfailure to recognize and failure to act. Other areas identified were failure in communication, paediatric problems, failure of equipment and patient responsibility. The group most frequently implicated is that of the junior medical staff.
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Closer examination of CTGs for the CESDI II/II cases (n=139 over the six periods) showed that most of the problems relate to failure to act on recognized abnormalities (62/139, 45%). However, failure to recognize an abnormality was also common (32/139, 23%). Poor-quality CTGs (18/139, 13%) and delayed response to recognized abnormalities were also important (33/139, 24%).
| DISCUSSION |
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Whilst the implementation of recommendations from the West Midlands Perinatal Audit, Crimson File and CESDI can be expected to reduce perinatal mortality, there is little evidence that better intrapartum care has much to contribute in terms of brain injury and long-term adverse outcomes6. Within the 5 years of the study, although our efforts to improve quality have been rewarded by a fall in indefensible care, the proportions of babies with low Apgar scores and low cord pH have not changed, nor are any fewer being admitted for neonatal intensive care. This is entirely in keeping with the growing opinion that better fetal monitoring and earlier recourse to caesarean section are unlikely to reduce cerebral palsy22,23. Nevertheless, improving the standards of intrapartum care is fundamental to minimizing medicolegal risk24,25. Were it possible to reduce indefensible care from 70% to less than 30%, the savings could run into many millions. Our system for monitoring and learning from mistakes is endorsed by recommendations in the key CESDI reports19,26.
NHS organizations are now charged with continuously improving the quality of their services and safeguarding high standards of care....27. Scally and Donaldson highlighted some of the deficiencies of clinical audit and emphasized the importance of learning from mistakes and of adverse incident reporting. Clinical risk management is therefore a key component of clinical governance28. Secker-Walker explains that introduction of clinical risk management takes many months and is only really successful when accompanied by a change in culture. All staff need to feel comfortable with the process. Our project has confirmed the need to be patient in terms of achieving improvements.
We are aware of further improvements required in training and risk management. One approach is the development of a series of videos to train midwives and doctors in various aspects of intrapartum care29,30,31. We hope that this will increase the uptake of training by the doctors in our team. Additionally, as recommended by CESDI26, we have made a computerized CTG training system available on labour ward32. Finally, the low-Apgar cases are now being considered at daily partogram audit and weekly adverse incidence meetings, to allow earlier feedback.
| Acknowledgments |
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| REFERENCES |
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