Clinical Studies Group for Preterm Birth (CSG)

Wednesday 30 May 2012 @ 13.00

Cancer Research UK, Angel Building, 407 St John Street, London

Present:

Professor Phil Bennett, Professor of Obstetrics, Imperial College (PRB)

Professor Jane Norman, Professor of Maternal and Fetal Health, University of Edinburgh (JN) (Chair)

Professor Steve Thornton, Peninsula College of Medicine and Dentistry (ST)

Professor David Field, BAPM Representative (DF)

Professor Neil Marlow, BAPM Representative (NM)

Dr Sara Kenyon, Birmingham (SK)

Professor Andrew Shennan, Professor Obstetrics, St. Thomas’ Hospital (AS) – Part of meeting

In Attendance

Nicola Cole, University of Edinburgh

1)Apologies
The following apologies were given:
Professor Siobhan Quenby (SQ)
Dr Sarah Stock (SS)
Dr Shalini Patni (SP)
Professor Peter Brocklehurst (PB)
Dr Rachel Tribe (RT)
Tracy Swinfield (TS)

2)CSG at BMFMS meeting
Good meeting 40+ attended and 1 project presentation:
COTS Study (Dr Fidan Bayli)
The preliminary outline for this study was presented. Considerable feedback was given to Dr Bayli and she has asked to present again this afternoon.
The group discussed having a joint CSG BMFMS meeting again next year. It was agreed that this would be a useful thing to do, provided there were a small number of relevant studies presented. There was a discussion about whether other meetings would be suitable places to host a CSG meeting – on balance it was felt that the BMFMS was probably the most appropriate venue. JN to look at organising a joint meeting.

(Action: JN –subsequently agreed by LP and SK)

3)Minutes of previous meeting
Were approved.

4)Update from planned projects
Grant applications

i)Cervical length indicated cervical cerclage in the management of pregnancy after cone biopsy PI Phil Bennett
Project is in and awaiting result. There were 3 rounds – expression of interest, outline and full application. Should find out by the summer whether or not it has been accepted at outline stage (note – since the meeting this project is now through to the “full” stage).
ii) Biomarker Prediction of Early Preterm Birth PI Phil Bennett
Went to the MRC Stratified Medicine Bid, they thought powerful but unsuited for the specific funding scheme. It has now been adapted and submitted to the Experimental Medicine Board. Should receive feedback in July before the full application deadline in September.
iii) Why are women who have cervical intraepithelial neoplasia at increased risk of preterm labour? PI Sarah Stock.SS and RT have put their project outline to AMR and currently working on full proposal for deadline 3 July 2012.

Projects discussed at BMFMS 2011

iv) Measuring placental transfusion for preterm birth.PI Duley. Funding - Programme grant from NIHR.Pilot is going ahead and due to start March 2013. There has been lots of enthusiasm from centres to participate.
v) Towards primary prevention of preterm births: Variation of biomarkers with deprivation and with other known risk factors for preterm births. PI Field. Currently being prepared as a bid to the MRC.
vi)Can personalised antenatal care for low risk women, based on a sequential risk assessments, increase the number of healthy mothers and babies born at term without significant increase in cost to NHS?PI Zarko Alfirevic. Was submitted to EME for the stratified medicine bid but was thought not to have been in remit. Is now beingrevised.
The group discussed how CSG review applications and ways of developing a better strategy. Currently CSG do not see a final version to be able to comment on it. SK discussed how the intrapartum CSG deal with proposals. The investigator is sent a standard form to complete and return. The project is reviewed by multidisciplinary members. One member leads on the proposal discussion. The investigator is then sent comments on a second standardised form. JN noted that so far CSG Preterm Birth have had a less formal approach towards reviews but is now considering keeping a database of all projects and comments made.
DF suggested developing a format for feedback. i.e. give applicants a date by which they will receive feedback, maybe clarify whether we require an outline or full proposal. He felt that more people would utilise this opportunity if they were aware of a specific process.
PB noted that it is good to have feedback in a professional capacity and a ‘stamp’ that the project has been reviewed by the CSG. However there definitely needs to be a submission format of some kind for applicants to the CSG, perhaps tailoring questions to the generic MRC grant questions. SK noted that many people have gone to the intrapartum care CSG for review but ignored the comments provided. Projects have subsequently gone forwardsaying they have the intrapartum CSG stamp of approval, despite having not adhered to the recommended changes.
The Chair of the CSG chairs has promised to produce a generic feedback letter/form, so it would probably be inappropriate for the PTB CSG to develop our own at this stage. The group agreed that their reviews should be kept informal but will discuss further when the generic form is circulated.

5)NIHR Project – Research Uncertainties in Preterm Birth (Unanswered Questions – survey)
JN gave a brief overview of the project which is designed to identify major research questions around preterm birth. AS is our representative on the group – he also represents RCOG.

6)Research priorities

The Chair of CSG meeting suggested that all CSGs should come up with their own research priorities. PTB CSG had previously done this – JEN will table this for the next meeting but it needs to be updated. SK noted that all the intrapartum CSG’s had recently come up with their own research priorities. This will be a major piece of work for the CSG and it was agreed we should have a half day meeting with consumer input etc in Sept to move this forward. JEN will contact consumer groups such as AMR and Tommys – any other suggestions for lay input would be welcomed.

Action: All – JEN to organise meeting, suggestions for other people to JEN please.

7)CSG Membership
Dr Rhona Hughesis no longer a member.

There was further discussion on expanding the group. The group agreed on the importance of having people with some engagement in the area and must understand research (i.e. format, words used etc). Also someone with broad knowledge and less focussed on certain areas. JEN will invite new clinical applicants just now and will liaise with those who have not come for some time to see if they wish to continue as members. Following our meeting with consumers in Sept we may be able to identify others who could join.

PB suggested getting statisticians to attend meetings and also midwives who are involved in research activity. It could be beneficial for the group to engage with those who are exposed to the issues/difficulties involved in research. The group agreed and SK suggested that midwives who are involved in preterm birth would be good. JN, PB, AS and SK to ask their midwives if they wish to participate. SK noted that having people attend (possibly midwives) as ‘observers’ might be a good idea.
Action: JN, PB, AS and SK

8)Date of next meeting Sept.
To be confirmed over Doodle request.