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Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial (2024)
Journal Article
Kendrick, D., Lindley, R., Blackburn, L., Roadevin, C., Thompson, E., Andrews, I., …Radford, K. (2024). Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial. Trials, 25(1), Article 439. https://doi.org/10.1186/s13063-024-08183-w

Background Moderately severe or major trauma (injury severity score (ISS) > 8) is common, often resulting in physical and psychological problems and leading to difficulties in returning to work. Vocational rehabilitation (VR) can improve return to w... Read More about Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial.

Bleeding with intensive versus guideline antiplatelet therapy in acute cerebral ischaemia (2023)
Journal Article
Woodhouse, L. J., Appleton, J. P., Christensen, H., Dineen, R. A., England, T. J., James, M., …Bath, P. M. (2023). Bleeding with intensive versus guideline antiplatelet therapy in acute cerebral ischaemia. Scientific Reports, 13, Article 11717. https://doi.org/10.1038/s41598-023-38474-2

Intensive antiplatelet therapy did not reduce recurrent stroke/transient ischaemic attack (TIA) events as compared with guideline treatment in the Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial, but did increase th... Read More about Bleeding with intensive versus guideline antiplatelet therapy in acute cerebral ischaemia.

Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure (2023)
Journal Article
Woodhouse, L. J., Montgomery, A. A., Pocock, S., James, M., Ranta, A., Bath, P. M., & TARDIS Investigators, T. I. (2023). Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure. Contemporary Clinical Trials Communications, 35, Article 101186. https://doi.org/10.1016/j.conctc.2023.101186

Background: Ordinalised vascular outcomes incorporating event severity are more informative than binary outcomes that just include event numbers. The TARDIS trial was the first vascular prevention study to use an ordinalised vascular outcome as its p... Read More about Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure.

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. (2023). Mental health in clinically referred children and young people before and during the Covid-19 pandemic. European Child and Adolescent Psychiatry, 32(12), 2657–2666. 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.

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.

Trends in hospital admissions for childhood fractures in England (2021)
Journal Article
Marson, B. A., Manning, J. C., James, M., Ikram, A., Bryson, D. J., & Ollivere, B. J. (2021). Trends in hospital admissions for childhood fractures in England. BMJ Paediatrics Open, 5(1), Article e001187. https://doi.org/10.1136/bmjpo-2021-001187

Purpose Fractures to the axial and appendicular skeleton are common in children causing loss of opportunities and disability. There are relatively few studies available to quantify the number of children who have their fractures diagnosed in the emer... Read More about Trends in hospital admissions for childhood fractures in England.

Correction: A Direct-to-Public Peer Support Program (Big White Wall) Versus Web-Based Information to Aid the Self-management of Depression and Anxiety: Results and Challenges of an Automated Randomized Controlled Trial (2021)
Journal Article
Morriss, R., Kaylor-Hughes, C., Rawsthorne, M., Coulson, N., Simpson, S., Guo, B., …Williams, L. (2021). Correction: A Direct-to-Public Peer Support Program (Big White Wall) Versus Web-Based Information to Aid the Self-management of Depression and Anxiety: Results and Challenges of an Automated Randomized Controlled Trial. Journal of Medical Internet Research, 23(7), Article e31543. https://doi.org/10.2196/31543

[This corrects the article DOI: 10.2196/23487.].

A direct-to-public peer support program (Big White Wall) versus web-based information to aid the self-management of depression and anxiety: Results and challenges of an automated randomized controlled trial (2021)
Journal Article
Rawsthorne, M., Tata, L., Williams, L., Morriss, R., Guo, B., Simpson, S., …Moran, P. (2021). A direct-to-public peer support program (Big White Wall) versus web-based information to aid the self-management of depression and anxiety: Results and challenges of an automated randomized controlled trial. Journal of Medical Internet Research, 23(4), Article e23487. https://doi.org/10.2196/23487

Background: Effective help for depression and anxiety reaches a small proportion of people who might benefit from it. The scale of the problem suggests the need for effective, safe web-based public health services delivered directly to the public. On... Read More about A direct-to-public peer support program (Big White Wall) versus web-based information to aid the self-management of depression and anxiety: Results and challenges of an automated randomized controlled trial.

Safety and cost-effectiveness of individualised screening for diabetic retinopathy: the ISDR open-label, equivalence RCT (2020)
Journal Article
Broadbent, D. M., Wang, A., Cheyne, C. P., James, M., Lathe, J., Stratton, I. M., …Harding, S. P. (2021). Safety and cost-effectiveness of individualised screening for diabetic retinopathy: the ISDR open-label, equivalence RCT. Diabetologia, 64(1), 56-69. https://doi.org/10.1007/s00125-020-05313-2

Aims/hypothesis: Using variable diabetic retinopathy screening intervals, informed by personal risk levels, offers improved engagement of people with diabetes and reallocation of resources to high-risk groups, while addressing the increasing prevalen... Read More about Safety and cost-effectiveness of individualised screening for diabetic retinopathy: the ISDR open-label, equivalence RCT.

Clinical and economic outcomes of remotely delivered cognitive behaviour therapy versus treatment as usual for repeat unscheduled care users with severe health anxiety: a multi-centre randomised controlled trial (2019)
Journal Article
Morriss, R., Patel, S., Mallins, S., Guo, B., Higton, F., James, M., …Tyrer, H. (2019). Clinical and economic outcomes of remotely delivered cognitive behaviour therapy versus treatment as usual for repeat unscheduled care users with severe health anxiety: a multi-centre randomised controlled trial. BMC Medicine, 17, 1-13. https://doi.org/10.1186/s12916-019-1253-5

Background: Repeat users of unscheduled health care with severe health anxiety are challenging to engage in psychological help and incur high service costs. We investigated whether clinical and economic outcomes were improved by offering remote cogni... Read More about Clinical and economic outcomes of remotely delivered cognitive behaviour therapy versus treatment as usual for repeat unscheduled care users with severe health anxiety: a multi-centre randomised controlled trial.

Outcomes of mindfulness-based stress reduction and mindfulness-based cognitive therapy in adults with diabetes: a systematic review (2018)
Journal Article
Mason, J., Meal, A., Shaw, I., & Adams, G. G. (in press). Outcomes of mindfulness-based stress reduction and mindfulness-based cognitive therapy in adults with diabetes: a systematic review. Journal of Diabetes and Treatment, 2018(2), https://doi.org/10.29011/2574-7568.000049

Objectives: Diabetes Mellitus (DM) is a global and progressive chronic medical condition with increasing prevalence and associated costs throughout the world. Psychological problems are common in people with DM and when they co-occur are associated w... Read More about Outcomes of mindfulness-based stress reduction and mindfulness-based cognitive therapy in adults with diabetes: a systematic review.

Protocol investigating the clinical utility of an objective measure of attention, impulsivity and activity (QbTest) for optimising medication management in children and young people with ADHD ‘QbTest Utility for Optimising Treatment in ADHD’ (QUOTA): a feasibility randomised controlled trial (2018)
Journal Article
Hall, C. L., James, M., Brown, S., Martin, J. L., Brown, N., Selby, K., …Groom, M. J. (2018). Protocol investigating the clinical utility of an objective measure of attention, impulsivity and activity (QbTest) for optimising medication management in children and young people with ADHD ‘QbTest Utility for Optimising Treatment in ADHD’ (QUOTA): a feasibility randomised controlled trial. BMJ Open, 8(2), Article e021104. https://doi.org/10.1136/bmjopen-2017-021104

Introduction: Attention-deficit hyperactivity disorder (ADHD) is characterised by symptoms of inattention, hyperactivity and impulsivity. To improve outcomes, the National Institute for Health and Care Excellence ADHD guidelines recommend regular mon... Read More about Protocol investigating the clinical utility of an objective measure of attention, impulsivity and activity (QbTest) for optimising medication management in children and young people with ADHD ‘QbTest Utility for Optimising Treatment in ADHD’ (QUOTA): a feasibility randomised controlled trial.

Protocol investigating the clinical outcomes and cost-effectiveness of cognitive–behavioural therapy delivered remotely for unscheduled care users with health anxiety: randomised controlled trial (2016)
Journal Article
Patel, S., Malins, S., Guo, B., James, M., Kai, J., Kaylor-Hughes, C., …Morriss, R. K. (2016). Protocol investigating the clinical outcomes and cost-effectiveness of cognitive–behavioural therapy delivered remotely for unscheduled care users with health anxiety: randomised controlled trial. BJPsych Open, 2, https://doi.org/10.1192/bjpo.bp.115.002220

Background Health anxiety and medically unexplained symptoms cost the National Health Service (NHS) an estimated £3 billion per year in unnecessary costs with little evidence of patient benefit. Effective treatment is rarely taken up due to issues s... Read More about Protocol investigating the clinical outcomes and cost-effectiveness of cognitive–behavioural therapy delivered remotely for unscheduled care users with health anxiety: randomised controlled trial.

ESCAPS study protocol: a feasibility randomised controlled trial of ‘Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm’ (2016)
Journal Article
Fletcher-Smith, J. C., Walker, D.-M., Sprigg, N., James, M., Walker, M. F., Allatt, K., …Pandyan, A. D. (2016). ESCAPS study protocol: a feasibility randomised controlled trial of ‘Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm’. BMJ Open, 6(1), Article e010079. https://doi.org/10.1136/bmjopen-2015-010079

Introduction Approximately 70% of patients with stroke experience impaired arm function, which is persistent and disabling for an estimated 40%. Loss of function reduces independence in daily activities and impacts on quality of life. Muscles in thos... Read More about ESCAPS study protocol: a feasibility randomised controlled trial of ‘Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm’.

Spending by primary care practices-does it show what we expect? (2013)
Journal Article
James, M., & Stokes, E. (2014). Spending by primary care practices-does it show what we expect?. International Journal of Health Planning and Management, 29(3), 244-259. https://doi.org/10.1002/hpm.2224

Background Over recent years, a number of policies and financial incentives in primary care have been proposed to tackle issues such as deprivation and health outcomes. This article investigates the association between healthcare spending, deprivati... Read More about Spending by primary care practices-does it show what we expect?.