Professor Andrew Weeks: The post partum haemorrhage (PPH) Butterfly – clinical testing and commercial development
Post Partum Haemorrhage (PPH), loss of blood after childbirth, is a common maternity emergency affecting 40,000 women across the UK each year. The incidence and severity of PPH is increasing and novel treatments are urgently needed.
The most common cause is failure of the womb to contract, and drugs are first administered to stimulate the womb to contract. If these fail, then the woman is taken into an operating theatre to find the source of the bleeding, and physical methods used to stop the bleeding under anaesthetic. A device that could simply ‘turn off the tap’, without the need for surgical intervention, would be a major advance in PPH management.
The PPH Butterfly is a completely new device. It is placed into the birth canal when bleeding starts and allows the doctor or midwife to stop the bleeding by squeezing the womb against it. It also detects whether the bleeding is coming from the womb or vaginal tears.
The National Institute for Health Research (NIHR) Inventions for Innovation (i4i) programme has funded the design and initial human testing of the device.
The study is being led by Andrew Weeks, Professor of International Maternal Health Care at the University of Liverpool, and Director of the Sanyu Research Unit.
The design will first be optimised for commercial production with assistance from our commercial partner. Simultaneously, a training package will be developed for staff at the recruiting hospital, and its effectiveness assessed in an observational study of 118 women with PPH at Liverpool Women’s Hospital. Interviews will be conducted with staff and recruited women to assess the device’s acceptability and usability. A health economics analysis will look at the costs of a PPH when managed traditionally, and when treated by the PPH Butterfly. Cost and clinical outcome data from recruited women will be compared with that of a historical cohort.
Following successful completion of the study, the device will be submitted for CE marking and a commercial review undertaken to assess the market potential of the device.
During the development of the stage 2 funding application, Professor Weeks and his team sought advice from the NIHR Research Design Service North West (RDS NW). On approaching the RDS NW the proposal was well worked up and as such the RDS NW provided a critical read of the proposal. Following the critical read, advice was provided on the statistical aspects of the proposal. The RDS NW also helped respond to reviewer’s comments following the project being offered conditional funding.
The RDS NW provides an advice service that covers all aspects of developing a research funding application in applied health and social care. From advice on formulating a research question, structuring and designing the proposal, research methods, public involvement to a critical reads of the proposal. For full details of the advice offered by the RDS NW visit the RDS NW website here.
This study was funded by the NIHR Invention for Innovation (i4i) programme.
The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Prof Fiona Lobban: IMPlementation of A Relatives’ Toolkit: Examining the critical success factors, barriers and facilitators to implementation of an online supported self-management intervention in the NHS (IMPART study)
The IMPART study, funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research (HS&DR) Programme (project number 14/04/16), successfully received funding following expert advice from the NIHR Research Design Service North West (RDS NW).
The study uses an iterative case series design in six NHS Trusts and examines the implementation process of an online support self-management intervention for relatives of people with psychosis / bipolar disorder in Early Intervention Services. This is an important study that aims to help reduce the evidence-practice gap and will have broad implications for digital development across healthcare settings.
See www.nets.nihr.ac.uk/projects/hsdr/140416 for more information on the study.
Led by Professor Fiona Lobban, Spectrum Centre for Mental Health Research, Lancaster University, the study was developed and is delivered in collaboration with a range of clinical academics, clinical health professionals, methodological experts and service users across UK Universities and NHS Trusts.
During the development of the funding application an RDS NW case manager led an advising team of three RDS NW advisers, including the case manager, in providing advice on the development of the funding application.
When the RDS NW was first approached, it was not clear which funding programme this project would be best suited to. The RDS NW enabled the identification of the appropriate funding programme, HS&DR, but also facilitated communication with other successful HS&DR applicants, enabling the application to fit the requirement of the programme. Through the RDS NW case manager, expert RDS NW methodologists were identified in key areas. These advisers enabled the project team to think through the most appropriate design. Advisers also provided support on the funding submission process including detailed feedback on draft submissions. The RDS NW also provided advice on user involvement in developing the application. Service users and relatives were involved in developing the study and are also involved in the delivery of the study.
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HS&DR Programme, NIHR, NHS or the Department of Health.
Dr Elizabeth Tyler: Developing and evaluating a psychological therapy for older adults with bipolar disorder
Dr Elizabeth Tyler, a clinical psychologist based at the Spectrum Centre for Mental Health at Lancaster University has recently been awarded a NIHR Doctoral Fellowship.
The research will focus on developing and testing out a recovery focused cognitive behavioural therapy (CBT) intervention for older adults with bipolar disorder (BD).
BD is a severe and chronic mental health problem that persists into older adulthood. Current estimates suggest around 0.5 per cent of people over 65 years of age are living with BD (Depp and Jeste, 2004). However this figure is set to rise as the UK experiences a rapid ageing of its population (United Nations, 2002). The National Institute for Clinical Excellence (NICE) guidelines for BD, 2006, highlight the absence of evidence for older adults with regards to psychosocial interventions and there are currently no published randomised controlled trials (RCT) studies evaluating psychosocial interventions for later life bipolar disorder.
The RDS NW were able to help Elizabeth in a number of areas including: trial design, mental health advice, structuring and writing the proposal and helping to review the application form.
RDS NW also carried out a mock interview which was found to be incredibly useful. It provided the opportunity to review the project with a number of academics who did not specialise in the area.
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.
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.”
Dr Anton Krige: A randomised controlled trial of thoracic epidural analgesia versus rectus sheath catheters for open midline incisions in major abdominal surgery within an Enhanced Recovery Program (TERSC)
Dr Anton Krige, a Consultant in Intensive Care Medicine and Anaesthesia as well as the Clinical lead for the Enhanced Recovery Programs at East Lancashire Hospitals NHS Trust, has a particular interest in providing good pain relief to patients after major surgery so that patients can recover quickly and avoid post-operative complications.
Dr Krige approached the RDS NW for advice on how to develop his research idea of comparing the most common approach of pain relief – epidural, and another approach – Rectus Sheath Catheters (RSCs). Epidurals, which use a fine tube being placed in the spine through which local anaesthetic is given, numbing the nerve supply to the abdomen and controlling the pain, can be very effective but they do have a number of possible side effects including common side effects such as headaches and low blood pressure as well as very rare side effects such as nerve injury.
Many of the side effects associated with epidurals do not apply to rectus sheath catheters and this may confer an advantage. However, no formal research had been conducted and so it is not known for sure which technique results in the best pain relief with the least side effects. This is the question that the TERSC research study aims to answer.
Dr Krige approached the RDS NW for general advice on how to apply for the RfPB programme and was allocated an adviser who initially explored the options for the appropriate research study design to develop to answer Dr Krige’s research questions. The adviser brought on board other methodological advisers as required in clinical trial design, qualitative methods and health economics.
Dr Krige and his team attended a dedicated advice support programme organised by the RDS NW for applicants to the RfPB programme.
The RDS NW also provided advice on how to develop the proposal further with PPI and these activities were supported by the RDS NW PPI bursary to facilitate the bringing together of past patients who had undergone such surgery in the past to advise on the most appropriate design and study materials ahead of a submission for RfPB funding.
Some of these patients have since agreed to stay with the project by being involved in managing and delivering the study now that patients are being recruited into the TERSC study.
This is the first research grant that Dr Krige has been awarded in his role as a hospital consultant.
The RDS NW were able to recommend other research methodologists who may be interested in supporting the application for funding and becoming co-applicants.