Edward Paddon-Bramley

RR From Ben Gummer MP
aS Parliamentary Under Secretary of State for Care Quality

Department Richmond House
79 Whiteha

of Health london
SWIA 2NS

POC 1023560
Tel: 020 7210 4860

Clerk to Senior Coroner

Inner Southern District of Greater London Borough of Southwark
The Coroners Court

Tennis Street

London

SELIYD Ih, vam

Thank you for Dr Morris’ letter to Secretary of State following the inquest into the
death of Edward Paddon-Bramley. I am responding as the Minister with portfolio
responsibility for maternity care at the Department of Health.

I was very sorry to read of Edward’s death and wish to extend my condolences to his
family.

Dr Morris’ report detailed the circumstances of Edward’s death and noted your
concerns about a difference of opinion and practice in the treatment of mothers (and
their babies) who suffer from prolonged ruptured membranes. You were specifically
concerned about the following:

¢ Trust guidelines as to the treatment of prolonged ruptured membranes (PROM)
differed from those provided by National Institute for Health and Care
Excellence (NICE) and the use of antibiotics, after varying times of rupture,
irrespective of the clinical picture.

e Consultants’ views as to the best practice for treating PROM and whether
women should be screened for GBS during pregnancy differed from those
provided by NICE.

¢ Both clinicians and Trusts appearing to be at odds with NICE.

¢ The arguable opinion that GBS screening in pregnant women together with the
use of intrapartum antibiotics ought to be reviewed.

NICE is the independent body that provides guidance on the prevention and treatment
of ill health, and the promotion of good health and social care. NICE’s guidance is
based on a thorough assessment of the available evidence and is developed through
wide consultation with stakeholders.

Its clinical guidelines represent best practice and cover a whole pathway of care
spanning all stages of care from the diagnosis to treatment of a condition. In
recognition of their complexity, they are not mandatory and do not override the
responsibility of healthcare professionals to make decisions appropriate to the
circumstances of the individual patient, in consultation with the patient and/or their
carer or guardian. We do however expect NHS clinicians to take them fully into
account when exercising their professional judgement, alongside the individual needs,
preferences and values of their patients.

NICE periodically reviews its guidance to take account of new evidence, service
developments and technologies. NICE is currently expecting to review the need to
update its clinical guideline on Inducing labour (CG70) in September 2016. The
clinical guideline is available at: www.nice.org.uk/guidance/cg70

The Royal College of Obstetricians and Gynaecologists (RCOG) has produced
guidance for obstetricians, midwives and neonatologists on the prevention of early-
onset neonatal group B streptococcal disease. This recommends that antibiotics should
be offered to women during labour where there are recognised risk factors for
transmission such as having had a previously affected baby, or where there has been
incidental identification of GBS during the current pregnancy. In addition, NICE
published a clinical guideline, Antibiotics for early-onset neonatal infection:
Antibiotics for the prevention and treatment of early-onset neonatal infection (CG149)
in August 2012 which addresses early onset GBS and other neonatal infections. The
clinical guideline is available at: www.nice.org.uk/guidance/cg149

The Department encourages obstetric units to have written protocols in place which
incorporate the RCOG’s guideline on the prevention of early-onset neonatal group B
streptococcal disease.

The UK National Screening Committee (UK NSC) advises Ministers and the NHS in
all four countries about all aspects of screening policy and supports implementation.
Using research evidence, pilot programmes and economic evaluation, it assesses the
evidence for programmes against a set of internationally recognised criteria. In the
case of screening for GBS carriage in pregnancy, the current evidence does not
support universal screening.

BS

Rese
Department
of Health

In November 2012, the UK NSC recommended that antenatal screening for GBS
carriage at 35-37 weeks of pregnancy should not be offered because there is
insufficient evidence to demonstrate that the benefits to be gained from screening
would outweigh the harms. The UK NSC highlighted that a screening programme
would lead to large numbers of predominantly low risk women being offered
antibiotics that they did not need. This is because the test cannot distinguish between
the small number of carriers whose babies would be affected by early onset GBS and
the large number which would not.

The UK NSC is currently reviewing its recommendation on antenatal screening for
GBS carriage as part of its three yearly review cycle and will be taking new published
evidence into account. A public consultation is expected to be held in the autumn for a
three month period. Following this the UK NSC will then review the recommendation
for screening for GBS carriage in pregnancy.

The current advice from the UK NSC is consistent with guidance from NICE and the
RCOG.

A range of work is being taken forward by the Department and Public Health England -
(PHE) with a range of partner organisations on preventing GBS infection. This
includes:

* monitoring developments on GBS vaccines and undertaking a grant-funded study
to assess the potential impact of a maternal immunisation programme.

e the British Paediatric Surveillance Unit in collaboration with PHE has just
completed the collection of data for a national surveillance study on GBS. The
analysis is ongoing and will provide an accurate, up to date, assessment of the
number of cases of both early and late onset disease. This is due to be published
in summer 2016 and the study will provide essential information for the UK
NSC’s review of screening for GBS.

e an audit in partnership with the London School of Hygiene and Tropical
Medicine and supported by the Royal College of Midwives was recently carried
out by the RCOG. It examined current practice in preventing early onset neonatal
Group B Streptococcal disease, by investigating the implementation of the
RCOG Green-top guideline on preventing the disease, and identified key areas
for improvement. The first report was published on 5 March 2015 and found that
the majority of obstetric units in the UK have written protocols to prevent early
onset GBS disease in newborn babies, however, there is still variation in practice

across units. The second report was published on 29 January 2016 and has made
recommendations for improvements in care in the prevention of early-onset GBS
disease.

¢ — the National Institute for Health Research has approved funding for a study on
accuracy of a rapid intrapartum test for maternal group B streptococcal
colonisation and its potential to reduce antibiotic usage in mothers with risk
factors (GBS2). This is expected to start this year.

I hope that you find tis reply helpful and I am grateful to you for bringing the
circumstances of Egward’s death to my attention.

BEN GUMMER

a

Floor 2, Zone B

Skipton House

80 London Road
London SE1 GLH

T +44 (0)20 3682 0923

N. Ss C UK National ; www.screening.nhs. uk
Screening Committee W@PHE Screening

Southwark Coroner's Court |
1 Tennis Street

Southwark

London

SE1 1YD

11 April 2016

Dear Mr Thompson

Re: Coroner Report and response to preventing future deaths (Edward
Paddon- Bramley)

Thank you for forwarding through the coroner report on the death of Edward
Paddon-Bramley. | was very sorry to read that

son,
Edward, died from complications of Group B Streptococcus (GBS) at 9 days old. The

death of a baby is devastating for parents and their families and | would like to offer
a my sympathy for thei tragic loss,

National screening policy is set by an expert Committee, the UK National Screening
Committee (UK NSC), which advises Ministers and the NHS about all aspects of
screening policy. In November 2012, the UK NSC recommended that antenatal
screening for GBS carriage should not be offered. This is because testing women in
late pregnancy to see if they carry GBS is not very effective in predicting whether the
baby is likely to be affected by early onset GBS disease. This means that thousands
of women in labour who carry GBS as a harmless bacterium would be offered
antibiotics they didn’t need. The balance of benefits and harms from this strategy is
uncertain. In December 2015 the UK NSC commissioned an update review into
antenatal screening for GBS as per its published process. A public consultation is
expected -to-be-held-in-the autumn-for-a-three-month period:-Following this-the-UK
NSC will then review the recommendation for screening for GBS in pregnancy.

| hope this addresses your concern about the need to review the current screening
policy. More information and how to contribute to the public consultation will be

available at the following link; http:/Aegacy.screening.nhs.uk/screening-
recommendations.php

In the UK, health professionals are advised to follow the risk-based guidance
established by NICE and the RCOG. Though it is not possible to comment on
individual cases, it appears that this case is relevant to that guidance. This is
because of the prolonged membrane rupture and chorioamnionitis described in your

Public Health England hosts the UK National Screening Committee ~

report. | note that NICE and. RCOG have received this report and they are better
placed to respond to the issues raised. However, it may be of interest to you to
know that research is currently underway to evaluate the value of using rapid tests in
labour to detect GBS in women with the kind of risk factors experienced by I

This is sponsored by the NIHR HTA Programme.

Again, | hope this reassures you that the issue of GBS infection in the newborn is
taken seriously and is being actively addressed at both policy and research levels.

Yours sincerely

Director of Programmes
UK National Screening Committee
anne.mackie@phe.gov.uk

a,