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.
Untreated, hydrocephalus can be life-threatening. The commonest treatment involves an operation to insert a tube into the swollen ventricles to drain off the excess fluid. This is called a ventriculoperitoneal shunt (VPS).
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).