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EMPiREnewsletterJune ‘14Well 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 – It’s 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 ArrowePark Hospital
Database Update
EMPiREnewsletter
All participant seizure diaries are currently being sent to the trial office where they are checked for completeness before being entered onto a temporary Access database. The trial office 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 Infirmary, 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 office, 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 file. 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 office 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 confirm 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 17.03.13SOP 2 Data Management Version 1 07.09.12SOP 3 Blood Collection & Processing Version 3 11.10.13
SOP 4 Adverse Event & SeriousAdverse Event Reporting
Version 3 30.07.12
SOP 5 Monitoring Version 3 02.05.13SOP 6 Training Version 1 16.07.12SOP 7 Randomisation & UnblindingNotification procedure
Version 1 23.04.13
SOP 8 Data quality check for sites Version 2 15.05.13
June ‘14
EMPiREnewsletter
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 certificate 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 Women’s Hospital recruitedthe 500th EMPiRE participant.
RECRUITMENT
JUN
E ’14REWARDS
Congratulations, Great Work!
Stafford General Hospital& Glan Clwyd Hospital
June ‘14
EMPiREnewsletter
SITE LEAD TABLE
June ‘14Approved Centre Name Date Site Opened Total
1 Birmingham Women’s Hospital 4-Nov-11 452 Royal Hallamshire Hospital 4-May-12 223 Queens Hospital, Romford 8-May-12 224 St Thomas’ Hospital 04-Jan-12 225 Liverpool Women’s Hospital 5-Jan-12 216 Newcastle Royal Infirmary 3-Feb-12 207 St Richard’s Hospital 20-Apr--12 188 St Georges Hospital 9-May-12 179 Glan Clwyd Hospital 28-Feb-13 16
10 Stafford Hospital 6-Jan-12 1511 Singleton Hospital, Swansea 13-Jul-12 1512 Royal Victoria Hospital, Belfast 1-Feb-13 1213 Royal Blackburn Hospital 17-Nov-11 1114 Colchester General Hospital 4-Jun-13 1115 Sunderland Royal Hospital 18-May-12 1016 Southampton General Hospital 20-Sep-12 1017 Chelsea & Westminster 22-Feb-13 1018 Leeds General Infirmary 13-Mar-13 1019 Southern General Hospital, Glasgow 17-May-13 1020 University Hospital of North Staffordshire 12-Jun-12 1021 Southend Hospital 20-Jul-12 922 The Royal Derby Hospital 10-Sep-12 923 Worcester Royal Hospital 12-Sep-12 924 Birmingham City Hospital 6-Sep-12 825 Royal Gwent Hospital, Newport 21-Sep-12 826 Leicester Royal Infirmary 31-Jan-13 827 Burnley General Hospital 22-Apr-13 828 John Radcliffe Hospital 24-Jul-13 829 Newham University Hospital 5-Jul-12 730 St Mary’s Hospital/Salford Hospital 26-Sep-12 731 Royal Shrewsbury Hospital 21-Nov-12 732 Royal Hampshire County Hospital 24-Apr-13 733 Coventry & Warwickshire 14-Jan-14 734 University Hospital Wales 30-Mar-12 635 The Royal London 16-May-12 6
EMPiREnewsletter
SITE LEAD TABLE:CONTINUED
“NB: Figures above do not include those recruited to qualitative study only or those enrolled in error”
follow us on Twitter: @kt_networkclick here to visit our website >>http://blizard.qmul.ac.uk/research-generation/254-empire.html<<
LIZ QUINLAN-JONES
EMPiRE Co-ordinating Research Midwife for
North England, Midlands & Wales
Email: [email protected]
Tel: 07826 512490
MUN LIM
EMPiRE Co-ordinating Research Nurse for
South England
Email: [email protected]
Tel: 07771 974713
RACHEL RIKUNENKO
EMPiRE Trial Co-ordinator
Women’s Health Research Unit
Email:[email protected]
Nhs.net email: [email protected]
Mobile: 07917 736924 Fax: 020 7 882 6047
LISA STARRS
EMPiRE Co-Ordinating Research Midwife for
ScotlandEmail:[email protected].
ukMobile: 07936 436 900
Tel: 0131 242 2667
MARIA D’AMICO
EMPiRE Data AssistantWomens Health
Research UnitEmail:Maria.d’amico@
nhs.netTel: 020 7882 6695Fax: 020 7882 6047
June ‘14Approved Centre Name Date Site Opened Total
36 Frimley Park Hospital 16-Jan-13 637 University Hospital North Durham 25--May-12 638 Bradford Royal Infirmary 19-Dec-12 539 Royal Sussex Hospital 5-Feb-13 540 Royal Cornwall 13-May-13 541 Warrington Hospital 24-Jun-13 542 Whipps Cross Hospital 10-Jan-13 443 Worthing Hospital 30-Apr--12 444 Nevill Hall Hospital, Abergavenny 21-Sep-12 345 Queen Alexandra Hospital, Portsmouth 23-May-13 346 Gloucester Royal Hospital 12-Apr-13 247 Northampton 19-Apr-13 248 Edinburgh Royal Infirmary 11-Jul-13 149 North Middlesex 24-Oct-13 150 Basingstoke & North Hampshire Hospital 24-Apr-13 0
Total 493
