Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial (2023)
Journal Article
Subhani, M., Enki, D. G., Knight, H., Jones, K. A., Sprange, K., Rennick-Egglestone, S., …Ryder, S. D. (2023). Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial. eClinicalMedicine, 61, Article 102069. https://doi.org/10.1016/j.eclinm.2023.102069

Background: Early identification followed by effective behaviour interventions is pivotal to changing the natural history of alcohol-related liver disease. We examined the feasibility of using transient elastography based advice and alcohol recovery... Read More about Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial.

Transient elastography and video recovery narrative access to support recovery from alcohol misuse: development of a novel intervention for use in community alcohol treatment services (2023)
Journal Article
Rennick-Egglestone, S., Subhani, M., Knight, H., Jones, K. A., Hutton, C., Jackson, T., …Ryder, S. (in press). Transient elastography and video recovery narrative access to support recovery from alcohol misuse: development of a novel intervention for use in community alcohol treatment services. JMIR Formative Research,

Background: Mortality from alcohol-related liver disease has risen significantly for three decades. Transient elastography (TE) is a non-invasive test providing a numerical marker of liver disease. Preliminary evidence suggests that receiving TE can... Read More about Transient elastography and video recovery narrative access to support recovery from alcohol misuse: development of a novel intervention for use in community alcohol treatment services.

Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study (2023)
Journal Article
Iflaifel, M., Sprange, K., Bell, J., Cook, A., Gamble, C., Julious, S. A., …Partlett, C. (2023). Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study. Trials, 24, Article 71. https://doi.org/10.1186/s13063-022-06992-5

Background: Existing guidelines recommend statisticians remain blinded to treatment allocation prior to the final analysis and that any interim analyses should be conducted by a separate team from the one undertaking the final analysis. However, ther... Read More about Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study.

Mental health in clinically referred children and young people before and during the Covid-19 pandemic (2022)
Journal Article
Sayal, K., Partlett, C., Bhardwaj, A., Dubicka, B., Marshall, T., Gledhill, J., …Montgomery, A. (2022). Mental health in clinically referred children and young people before and during the Covid-19 pandemic. European Child and Adolescent Psychiatry, https://doi.org/10.1007/s00787-022-02115-2

The Covid-19 pandemic and mitigation approaches, including lockdowns and school closures, are thought to have negatively impacted children and young people’s (CYP) mental health. However, the impact for clinically referred CYP is less clear. We inves... Read More about Mental health in clinically referred children and young people before and during the Covid-19 pandemic.

Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units (2022)
Journal Article
Iflaifel, M., Partlett, C., Bell, J., Cook, A., Gamble, C., Julious, S., …Sprange, K. (2022). Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units. Trials, 23(1), Article 535. https://doi.org/10.1186/s13063-022-06481-9

Background: Blinding is an established approach in clinical trials which aims to minimise the risk of performance and detection bias. There is little empirical evidence to guide UK clinical trials units (CTUs) about the practice of blinding statistic... Read More about Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units.

Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing? (2022)
Journal Article
Mitchell, E. J., Sprange, K., Treweek, S., & Nixon, E. (2022). Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?. Trials, 23, Article 457. https://doi.org/10.1186/s13063-022-06417-3

Marketing is a core business function in commercial companies but is also frequently used by not-for-profit organisations. Marketing focuses on understanding what people value to make choices about engaging with a product or service: a concept also k... Read More about Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?.

STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial (2022)
Journal Article
Day, F., Wyatt, L., Bhardwaj, A., Dubicka, B., Ewart, C., Gledhill, J., …Sayal, K. (2022). STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial. BMJ Open, 12(5), Article e053043. https://doi.org/10.1136/bmjopen-2021-053043

INTRODUCTION: Emotional disorders (such as anxiety and depression) are associated with considerable distress and impairment in day-to-day function for affected children and young people and for their families. Effective evidence-based interventions a... Read More about STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial.

The Journeying through Dementia psychosocial intervention versus usual care study: a two-arm, phase 3, superiority randomised controlled trial (2022)
Journal Article
Mountain, G., Cooper, C., Wright, J., Walters, S., Lee, E., Craig, C., …Young, E. (2022). The Journeying through Dementia psychosocial intervention versus usual care study: a two-arm, phase 3, superiority randomised controlled trial. Lancet Healthy Longevity, 3(4), e276-e285. https://doi.org/10.1016/S2666-7568%2822%2900059-9

Background There is an urgent clinical need for evidence based psychosocial interventions for people with mild dementia. We aimed to determine clinical and cost-effectiveness of Journeying through Dementia (JtD), an intervention designed to promote w... Read More about The Journeying through Dementia psychosocial intervention versus usual care study: a two-arm, phase 3, superiority randomised controlled trial.

The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention (2021)
Journal Article
Berry, K., Wright, J., Sprange, K., Cooper, C., Courtney-Walker, R., & Mountain, G. (2021). The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention. Brain and Behavior, 11(12), Article e2436. https://doi.org/10.1002/brb3.2436

Objective: A key challenge in delivering pragmatic trials of complex interventions is effective implementation within the study period and beyond. We describe a trial of an intervention to improve quality of life in mild dementia (Journeying through... Read More about The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention.

Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled trial (2021)
Journal Article
Subhani, M., Jones, K. A., Sprange, K., Rennick-Egglestone, S., Knight, H., Morling, J. R., …Ryder, S. D. (2021). Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled trial. BMJ Open, 11(11), Article e054954. https://doi.org/10.1136/bmjopen-2021-054954

Introduction Heavy drinkers in contact with alcohol services do not routinely have access to testing to establish the severity of potential liver disease. Transient elastography by FibroScan can provide this information. A recent systematic review su... Read More about Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled trial.