Dr Angharad Care: Three arm Pilot Randomised Controlled Trial to investigate the impact of progesterone vs. Arabin pessary vs. cerclage in high risk women with a short cervix to prevent pre-term birth

Dr Angharad Care and team from the Liverpool Womens NHS Foundation Trust were successful in obtaining NIHR Research for Patient Benefit(RfPB) of nearly £195000 following advice from RDS NW.

The study was a three arm controlled trial using three different treatments to control and prevent early pre-term labour in pregnancy.

Dr Care approached the RDS NW requesting advice on formulating her research question, structuring the proposal, qualitative aspects of the proposal and trial design.

The RDS NW provided advice on these areas but also identified other areas in which the proposal could be strengthened.

RDS NW identified that there was also very little patient and public involvement (PPI) in early drafts of the application and to overcome this Dr Care was advised to apply for an RDS NW PPI bursary to help develop a strong partnership with lay people who can help with elements of trial design, recruitment strategies and input to the design of patient information sheets and consent forms. Dr Care was advised to contact the Research User Group at her Trust and arrange to present her work to them and get their feedback.

Dr Care needed to strengthen her team and RDS NW advised her to include clinicians, a
statistician, a health economist, a lay applicant, research midwives and a Clinical Trials Unit (CTU). There was also a need to involve the Trust R&D department and the Clinical Research Network (CRN) to help with staff support costs and general administration of the application.

Dr Care was advised to strengthen the ‘need for the research’ element of the proposal, giving an idea of national incidence and prevalence rates, an outline of NHS and maternal/neonatal costs and how much the work could benefit both NHS and women themselves. A high patient benefit trajectory also needed to be underlined, which is
particularly important for a RfPB application.

Dr Care was asked what she found useful about the service, she responded,

“My RDS NW adviser, Dr Anne Rannard, was helpful from the start. In addition to critiquing the application she helped plan my timeline up to the deadline for the application and gave me realistic expectations of how long it would take me to get e.g. clinical trials unit involvement for my project and additionally helped me develop the PPI aspect of the project.”