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.
Prof Martin Tickle: A randomised controlled trial comparing the quality of life (QoL) and masticatory efficiency of patients with implant-retained (IRMO) compared with mini-implant-retained mandibular overdentures (MIRMO).
It is estimated that there are over three million people in the UK who have no teeth at all. There is national and international evidence that these patients should be provided with dental implants in the lower jaw to help to retain their lower denture. However, this treatment is costly and considered invasive by potential patients.
A team at the University of Manchester Dental Hospital, led by Professor Martin Tickle and Dr Craig Barclay, have secured a NIHR Research for Patient Benefit (RfPB) award of £250,000 to fund a pilot randomised controlled trial comparing standard dental implants to smaller diameter ‘mini’ implants, which are cheaper and simpler to place.
The project was also awarded a PPI bursary from RDS NW to help with the inclusion of PPI in the proposal development.
Mark Harrison and Tanya Walsh from the RDS NW Greater Manchester team provided advice in areas including: evaluation design, health economics, statistics, trial design and they also critically read the proposal.
Warm thanks to all those who helped facilitate
Dr Paul McNamara: A pilot study to assess whether humidified oxygen is more effective than standard oxygen therapy in treating children with acute severe asthma
Asthma is a big problem in the UK with about 1.1 million children having this condition and 30,000 hospitalised with it every year. About a third of children admitted to hospital need oxygen during their stay. Often this is given as cold, dry oxygen, piped straight from the wall. However, there are very good physiological reasons why oxygen therapy given for acute severe asthma attacks should be warmed and humidified. We want to find out which is the best way of giving oxygen to these children. We have recently been successful in applying for a RfPB grant to study this further. At Alder Hey Children’s Hospital, we have enough children admitted with acute severe asthma to undertake a pilot study to work out what outcomes will be most important to measure in a definitive multi-centre study. The RDS NW were fantastically helpful in aiding the development of this application through their advisers and seminars – we couldn’t have done it without their help!
Mr. Conor Laurence Mallucci: The British Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts multicentre randomised controlled trial
The British Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts multicentre randomised controlled trial (The BASICS trial) led by Mr. Conor Laurence Mallucci, Consultant Neurosurgeon, Alder Hey Children’s Hospital, received Health Technology Assessment (HTA) funding in excess of £2 million with support from the Research Design Service North West (RDS NW).
Hydrocephalus (commonly known as “water on the brain”) is a condition that can affect all age groups from babies to the elderly. In hydrocephalus, there is an accumulation of the normal brain fluid within the fluid cavities (ventricles) of the brain.
In the UK, 3000-3500 shunt operations are performed each year. One of the main risks of a shunt operation is infection (surgical meningitis), which results in the need for further surgery, antibiotic treatment and prolonged hospitalisation. It can have lifelong consequences, affect intellectual function and can be life-threatening.
Two new devices have been introduced to try to reduce shunt infection; antibiotic-impregnated (Bactiseal) and silver-impregnated (Silverline) shunts. This study will compare these new shunts to standard shunts in a study called a randomised multi-centre controlled trial. There has never been a similar trial to compare these shunts on such a scale. This will be a national trial recruiting 1200 participants from specialist neurosurgical units. The goal is to establish which VPS provides most protection against infection and the long term goal thereafter is to inform NHS policy and to ensure standardisation of care and infection rates across the country.
In addition, the research team will be exploring the impact that infection could have on participants in terms of hospital stay, post-operative complications and the potential cost to participants and the NHS. This team is well placed to carry out this research and already has experience of projects in similar settings.
The project team received advice from the RDS NW in a number of areas including trial design and sample size calculations from frontline adviser Dr Steven Lane.
Health economics advice was provided by Prof. Dyfrig Hughes, senior adviser for RDS NW. The project team also asked for help in finding a collaborator and as a result Dyfrig agreed to be a co-applicant on the bid.
The nature of the advice given covered all aspects of the economics and an overview of the proposal. This included which costs should be included in the analysis, in this case it was an NHS perspective so these will be secondary care costs only, and include catheters, duration of intensive care stay and hospital admission, antibiotic treatment, and contact with health professionals. Resource use data will be based on entries in the hospital records, and analysis of Hospital Episode Statistics. Given that the economic question under consideration is one of technical efficiency, the advice was to approach this as a cost-effectiveness analysis, based on the incremental cost per shunt failure averted. Secondary economic outcomes will include: (i) incremental cost per shunt infection avoided; and (ii) incremental cost per Quality-adjusted Lifeyear (QALY) gained. Stratified cost-effectiveness analyses will be conducted on important, pre-specified patient subgroup (including neonates, patients under 1 year old).