Optimising support and retention of patients enrolled in severe traumatic brain injury clinical trials: a mixed-methods study

Theme: Implementation

Project Description

Traumatic brain injury is a major global health concern that affects over 10 million people across the world each year. Severe traumatic brain injury is the leading cause of death and disability in people under 40 years old in the UK and other high-income countries. Clinical trials across the brain injury care pathway are essential for improving outcomes. However, a key challenge in conducting these trials is attrition (people dropping out of a study). This is important as attrition may bias the results leading to uncertainty as to whether or not a treatment is beneficial. There is an urgent need to optimise follow-up in brain injury studies.

The PhD project

Aim: Conduct a mixed-methods study to develop and evaluate strategies to optimize patient follow-up in traumatic brain injury clinical trials.

Work package one (systematic review): Review of quantitative and qualitative studies that explore strategies to optimize engagement and retention of individuals enrolled in studies of brain injury and other causes of cognitive impairment.

Work package two (Co-production of novel intervention): Series of co-production workshops with key stakeholders (patients/ carers, trial teams, clinicians) to develop an evidence- and theory-informed novel strategy.

Work package three (RCT): Undertake a randomised controlled trial of the new intervention, embedded in an upcoming NIHR funded brain injury trial. The statistical analysis will be complemented by semi-structured interviews.

Training

The student will receive training in relevant research methods, including systematic reviews, qualitative research, co-production methodology, and randomized controlled trials. The project would suit individuals from a range of professional backgrounds, including psychology, nursing, speech and language therapy, and paramedicine.

Outputs

The project will develop key new evidence on how to optimize the retention of participants in randomized controlled trials, thereby paving the way for more reliable trial evidence on the effectiveness of treatments in traumatic brain injury.

Supervisory Team

Professor Keith Couper

Professor Keith Couper

Professor in Emergency and Critical Care

Dr Rebecca Kandiyal

Dr Rebecca Kandiyal

Associate Professor in Health Economics