EMPiRE

newsletter
June 14
Well done to everyone
who recruited in May. We
have now recruited a total
of 500 participants (213
randomised) to the trial. This
is a fantastic achievement! Thank
you for all your hard work.
Please keep recruiting!
Arrowe Park Hospital
received R & D approval
in May 2014 to join
EMPiRE Its great to have
them on board.
We really appreciate all your
efforts in helping to enter data
onto the EMPiRE database now
that it is active. We know
that this can be a time
consuming task so thank
you for all your hard work.
20 of the 51 sites have
entered data so far.
We submitted our extension request for EMPiRE
on the 15.05.14 and HTA have agreed to extend
recruitment, provisionally, until the end of August
2014 whilst they make their decision about our
proposal. If our request is agreed, EMPiRE will
continue to recruit until November 2016 and be
fully completed by April 2018.
It is hoped that we will have a response to our
request by the end of August 2014, so we will
keep you updated.
Some of you may recall that we set up an EMPiRE
blog, in collaboration with Epilepsy Action, last
year. We would like to re-launch this blog, which
can be located using the following link:
https://www.epilepsy.org.uk/research/partnerships/
empire/blog/20130318
Please take a look at the link and encourage any
enthusiastic participants to comment about their
experience of the trial.
EMPiRE Extension
EMPiRE Blog
Recruitment!
Welcome to Arrowe
Park Hospital
Database Update
EMPiRE
newsletter
All participant seizure diaries are currently
being sent to the trial offce where they are
checked for completeness before being entered
onto a temporary Access database. The trial
offce team will transfer all diaries onto the live
EMPiRE main database over coming weeks and
will continue to use the main database to enter
diary data throughout the lifetime of the trial.
Recently, Leeds General Infrmary, when
entering participant data onto the main database
also entered the dates that the participant
seizure diaries run from. This has helped them
record which diaries they have photocopied and
sent to Maria. It also allows us, at the trial offce,
to marry up the diaries that have been received
with the records held on the database so we can
check if any diaries are missing on fle. We would
be grateful if all sites to do the same from now
onwards.
Within the antenatal follow up booklets (fetal
growth scan section) and the delivery booklet
there is a requirement sites to note down the
birth weight by centile for each baby. As not
all sites are using customised weight charts for
measuring growth and birth weight, the trial
offce will need to work out this information,
using the appropriate software, so it can be
entered onto the database.
We would be grateful if you could confrm
whether as a site you are measuring antenatal
growth and delivery weight by customised
centile so that we can enter this information for
you.
If you have not done so already please ensure that
the completed signature pages of all current SOPs
are faxed to Malika on 020 7882 6047:

All SOPs should be signed by appropriate members
of your local research team.
REMINDERS:
EMPiRE diaries on the database
Birth centiles in the CRF
Standard Operating Procedures (SOP)
front covers
SOP 1 Informed Consent Version 4 17.03.13
SOP 2 Data Management Version 1 07.09.12
SOP 3 Blood Collection & Processing Version 3 11.10.13
SOP 4 Adverse Event & Serious
Adverse Event Reporting
Version 3 30.07.12
SOP 5 Monitoring Version 3 02.05.13
SOP 6 Training Version 1 16.07.12
SOP 7 Randomisation & Unblinding
Notifcation procedure
Version 1 23.04.13
SOP 8 Data quality check for sites Version 2 15.05.13
June 14
EMPiRE
newsletter
Calculating recruitment rate according to birth numbers at each unit:
You get**15 in M&S gift vouchers**
and members of your research
team will soon receive a certifcate
acknowledging your hard work for
the month. Keep an eye on your post.
Everyone else, keep at it, next month
it could be you!
The Best Recruiter in May was:
Stafford Team:
PI: Mr Phil Tittensor
Research Midwife: Helen Millward
Glan Clwyd Team:
PI: Dr Maggie Armstrong
Research Midwife: Sarah Davies | Epilepsy Specialist Nurse: Sheila Shepley
Followed by St. Richards Hospital, Chichester (2nd place)
& Southern General Hospital, Glasgow (3rd place)
+ Liverpool Womens Hospital recruited
the 500th EMPiRE participant.
RECRUITMENT
J
U
N
E

1
4
REWARDS
Congratulations, Great Work!
Stafford General Hospital
& Glan Clwyd Hospital
June 14
EMPiRE
newsletter
SITE LEAD TABLE
June 14
Approved Centre Name Date Site Opened Total
1 Birmingham Womens Hospital 4-Nov-11 45
2 Royal Hallamshire Hospital 4-May-12 22
3 Queens Hospital, Romford 8-May-12 22
4 St Tomas Hospital 04-Jan-12 22
5 Liverpool Womens Hospital 5-Jan-12 21
6 Newcastle Royal Infrmary 3-Feb-12 20
7 St Richards Hospital 20-Apr--12 18
8 St Georges Hospital 9-May-12 17
9 Glan Clwyd Hospital 28-Feb-13 16
10 Staford Hospital 6-Jan-12 15
11 Singleton Hospital, Swansea 13-Jul-12 15
12 Royal Victoria Hospital, Belfast 1-Feb-13 12
13 Royal Blackburn Hospital 17-Nov-11 11
14 Colchester General Hospital 4-Jun-13 11
15 Sunderland Royal Hospital 18-May-12 10
16 Southampton General Hospital 20-Sep-12 10
17 Chelsea & Westminster 22-Feb-13 10
18 Leeds General Infrmary 13-Mar-13 10
19 Southern General Hospital, Glasgow 17-May-13 10
20 University Hospital of North Stafordshire 12-Jun-12 10
21 Southend Hospital 20-Jul-12 9
22 Te Royal Derby Hospital 10-Sep-12 9
23 Worcester Royal Hospital 12-Sep-12 9
24 Birmingham City Hospital 6-Sep-12 8
25 Royal Gwent Hospital, Newport 21-Sep-12 8
26 Leicester Royal Infrmary 31-Jan-13 8
27 Burnley General Hospital 22-Apr-13 8
28 John Radclife Hospital 24-Jul-13 8
29 Newham University Hospital 5-Jul-12 7
30 St Marys Hospital/Salford Hospital 26-Sep-12 7
31 Royal Shrewsbury Hospital 21-Nov-12 7
32 Royal Hampshire County Hospital 24-Apr-13 7
33 Coventry & Warwickshire 14-Jan-14 7
34 University Hospital Wales 30-Mar-12 6
35 Te Royal London 16-May-12 6
EMPiRE
newsletter
SITE LEAD TABLE:
CONTINUED
NB: Figures above do not include those recruited to qualitative study only or those enrolled in error
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LIZ QUINLAN-JONES
EMPiRE Co-ordinating
Research Midwife for
North England,
Midlands
& Wales
Email: elizabeth.quinlan-
jones@nhs.net
Tel: 07826 512490
MUN LIM
EMPiRE Co-ordinating
Research Nurse for
South England
Email: MunN.Lim@
bartshealth.nhs.uk
Tel: 07771 974713
RACHEL RIKUNENKO
EMPiRE Trial Co-
ordinator
Womens Health
Research Unit
Email:r.a.rikunenko@
qmul.ac.uk
Nhs.net email: rachel.
rikunenko@nhs.net
Mobile: 07917 736924
Fax: 020 7 882 6047
LISA STARRS
EMPiRE Co-Ordinating
Research Midwife for
Scotland
Email:Lisa.Starrs@ed.ac.
uk
Mobile: 07936 436 900
Tel: 0131 242 2667
MARIA DAMICO
EMPiRE Data Assistant
Womens Health
Research Unit
Email:Maria.damico@
nhs.net
Tel: 020 7882 6695
Fax: 020 7882 6047
June 14
Approved Centre Name Date Site Opened Total
36 Frimley Park Hospital 16-Jan-13 6
37 University Hospital North Durham 25--May-12 6
38 Bradford Royal Infrmary 19-Dec-12 5
39 Royal Sussex Hospital 5-Feb-13 5
40 Royal Cornwall 13-May-13 5
41 Warrington Hospital 24-Jun-13 5
42 Whipps Cross Hospital 10-Jan-13 4
43 Worthing Hospital 30-Apr--12 4
44 Nevill Hall Hospital, Abergavenny 21-Sep-12 3
45 Queen Alexandra Hospital, Portsmouth 23-May-13 3
46 Gloucester Royal Hospital 12-Apr-13 2
47 Northampton 19-Apr-13 2
48 Edinburgh Royal Infrmary 11-Jul-13 1
49 North Middlesex 24-Oct-13 1
50 Basingstoke & North Hampshire Hospital 24-Apr-13 0
Total 493