The clinical and cost effectiveness of a STAndardised DIagnostic Assessment for children and adolescents with emotional difficulties (STADIA); multi- centre randomised controlled trial
(2024)
Journal Article
Sayal, K., Wyatt, L., Partlett, C., Ewart, C., Bhardwaj, A., Dubicka, B., Marshall, T., Gledhill, J., Lang, A., Sprange, K., Thomson, L., Moody, S., Holt, G., Bould, H., Upton, C., Keane, M., Cox, E., James, M., & Montgomery, A. (in press). The clinical and cost effectiveness of a STAndardised DIagnostic Assessment for children and adolescents with emotional difficulties (STADIA); multi- centre randomised controlled trial. Journal of Child Psychology and Psychiatry,
All Outputs (49)
Development of a Vocational Rehabilitation Intervention to support Return to Work and Wellbeing following Major Trauma: A Person-Based Approach (2024)
Journal Article
Radford, K., Kettlewell, J., das Nair, R., Morriss, R., Holmes, J., Kellezi, B., Timmons, S., Jones, T., Tressider, H., Andrews, I., Bridger, K., Patel, P., Lindley, R., De Dios Perez, B., Statham, A., Jones, T., Hoffman, K., James, M., Kendrick, D., & ROWTATE study team. (2024). Development of a Vocational Rehabilitation Intervention to support Return to Work and Wellbeing following Major Trauma: A Person-Based Approach. BMJ Open, 14(10), Article e085724. https://doi.org/10.1136/bmjopen-2024-085724Objectives: Major trauma centres save lives but rehabilitation to support return-to-work (RTW) is lacking. This paper describes development of a vocational rehabilitation intervention (the ROWTATE intervention) to support RTW following traumatic inju... Read More about Development of a Vocational Rehabilitation Intervention to support Return to Work and Wellbeing following Major Trauma: A Person-Based Approach.
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., Anwar, F., Brooks, A., Carlton, E., Crouch, R., Day, F., Fallon, S., Farrin, A., Graham, L., Hoffman, K., Howell, R., Holmes, J., James, M., Jones, T., Kellezi, B., …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-wBackground
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., Krishnan, K., Montgomery, A. A., Ranta, A., Robinson, T. G., Sprigg, N., & 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/s41598-023-38474-2Intensive 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.2023.101186Background: 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., Ewart, C., James, M., Lang, A., Sprange, K., & 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/s00787-022-02115-2The 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., James, M., Lang, A., Marshall, T., Montgomery, A., Reynolds, S., Sprange, K., Thomson, L., Bradley, E., Lathe, J., Newman, K., Partlett, C., Starr, K., & 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-2021-053043INTRODUCTION: 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-2021-001187Purpose 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., James, M., Lathe, J., Moran, P., Tata, L. J., & 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.].
Correction to: Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial (2021)
Journal Article
Williams, L., Hall, C. L., Brown, S., Guo, B., James, M., Franceschini, M., Clarke, J., Selby, K., Vijayan, H., Kulkarni, N., Brown, N., Sayal, K., Hollis, C., & Groom, M. J. (2021). Correction to: Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial. Pilot and Feasibility Studies, 7, Article 94. https://doi.org/10.1186/s40814-021-00830-2
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., Coulson, N., Kaylor-Hughes, C., James, M., Lathe, J., & 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/10.2196/23487Background: 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.
Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial (2021)
Journal Article
Williams, L., Hall, C. L., Brown, S., Guo, B., James, M., Franceschini, M., Clarke, J., Selby, K., Vijayan, H., Kulkarni, N., Brown, N., Sayal, K., Hollis, C., & Groom, M. J. (2021). Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial. Pilot and Feasibility Studies, 7, Article 68. https://doi.org/10.1186/s40814-021-00788-1Background
Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of t... Read More about Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised 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., Roberts, J., Moitt, T., Vora, J. P., Gabbay, M., García-Fiñana, 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/s00125-020-05313-2Aims/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.
Outcomes of a public health campaign and automated randomised controlled trial of a direct to public peer support programme (Big White Wall) versus web-based information to aid self-management of depression and anxiety (The REBOOT study) (2020)
Preprint / Working Paper
Morriss, R., Kaylor-Hughes, C., Rawsthorne, M., Coulson, N., Simpson, S., Guo, B., James, M., Lathe, J., Moran, P., Tata, L., & Williams, L. Outcomes of a public health campaign and automated randomised controlled trial of a direct to public peer support programme (Big White Wall) versus web-based information to aid self-management of depression and anxiety (The REBOOT study)Background:
Effective help for depression and anxiety only reaches a small proportion of those who might benefit from it. The scale of the problem suggests a role for effective, safe public health online services delivered directly to the public. On... Read More about Outcomes of a public health campaign and automated randomised controlled trial of a direct to public peer support programme (Big White Wall) versus web-based information to aid self-management of depression and anxiety (The REBOOT study).
Connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment-resistant moderate to severe depression: study protocol for a randomised double-blind controlled trial (BRIGhTMIND) (2020)
Journal Article
Morriss, R., Webster, L., Abdelghani, M., Auer, D., Barber, S., Bates, P., Blamire, A., Briley, P. M., Brookes, C., Iwabuchi, S., James, M., Kaylor-Hughes, C., Lankappa, S., Liddle, P., McAllister-Williams, H., O’Neill-Kerr, A., Pszczolkowski Parraguez, S., Suazo Di Paola, A., Thomson, L., & Walters, Y. (2020). Connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment-resistant moderate to severe depression: study protocol for a randomised double-blind controlled trial (BRIGhTMIND). BMJ Open, 10(7), Article e038430. https://doi.org/10.1136/bmjopen-2020-038430Introduction The BRIGhTMIND study aims to determine the clinical effectiveness, cost effectiveness and mechanism of action of connectivity guided intermittent Theta Burst Stimulation (cgiTBS) versus standard repetitive Transcranial Magnetic Stimulati... Read More about Connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment-resistant moderate to severe depression: study protocol for a randomised double-blind controlled trial (BRIGhTMIND).
CORE-Kids: a protocol for the development of a core outcome set for childhood fractures (2020)
Journal Article
Marson, B. A., Marson, B., Manning, J. C., James, M., Craxford, S., Deshmukh, S., & Ollivere, B. (2020). CORE-Kids: a protocol for the development of a core outcome set for childhood fractures. BMJ Open, 10(2), Article e036224. https://doi.org/10.1136/bmjopen-2019-036224Introduction
Limb fractures in children are common yet there are few trials that compare treatments for these injuries. There is significant heterogeneity in the outcomes reported in the paediatric orthopaedic literature, which limits the ability... Read More about CORE-Kids: a protocol for the development of a core outcome set for childhood fractures.
The ESCAPS study: a feasibility randomized controlled trial of early electrical stimulation to the wrist extensors and flexors to prevent post-stroke complications of pain and contractures in the paretic arm (2019)
Journal Article
Fletcher-Smith, J. C., Pandyan, A. D., Fletcher-Smith, J. C., Walker, D. M., Allatt, K., Sprigg, N., James, M., Ratib, S., Boadu, J., Richardson, C., & Pandyan, A. D. (2019). The ESCAPS study: a feasibility randomized controlled trial of early electrical stimulation to the wrist extensors and flexors to prevent post-stroke complications of pain and contractures in the paretic arm. Clinical Rehabilitation, 33(12), 1919-1930. https://doi.org/10.1177/0269215519868834© The Author(s) 2019. Objective: To establish feasibility of initiating electrical stimulation treatment of wrist extensors and flexors in patients early after stroke to prevent muscle contractures and pain. Design: Feasibility randomized controlled... Read More about The ESCAPS study: a feasibility randomized controlled trial of early electrical stimulation to the wrist extensors and flexors to prevent post-stroke complications of pain and contractures in the paretic arm.
Consensus workshops on the development of an ADHD medication management protocol using QbTest: developing a clinical trial protocol with multidisciplinary stakeholders (2019)
Journal Article
Hall, C. L., Brown, S., James, M., Martin, J. L., Brown, N., Selby, K., Clarke, J., Williams, L., Sayal, K., Hollis, C., & Groom, M. J. (2019). Consensus workshops on the development of an ADHD medication management protocol using QbTest: developing a clinical trial protocol with multidisciplinary stakeholders. BMC Medical Research Methodology, 19, 1-13. https://doi.org/10.1186/s12874-019-0772-2Background
The study design and protocol that underpin a randomised controlled trial (RCT) are critical for the ultimate success of the trial. Although RCTs are considered the gold standard for research, there are multiple threats to their validity... Read More about Consensus workshops on the development of an ADHD medication management protocol using QbTest: developing a clinical trial protocol with multidisciplinary stakeholders.
Individualised screening for diabetic retinopathy: the ISDR study—rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening (2019)
Journal Article
Broadbent, D. M., Sampson, C. J., Wang, A., Howard, L., Williams, A. E., Howlin, S. U., Appelbe, D., Moitt, T., Cheyne, C. P., Rahni, M. M., Kelly, J., Collins, J., García-Fiñana, M., Stratton, I. M., James, M., & Harding, S. P. (2019). Individualised screening for diabetic retinopathy: the ISDR study—rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening. BMJ Open, 9(6), Article e025788. https://doi.org/10.1136/bmjopen-2018-025788Introduction: Currently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually. Resources are not increasing despite a 5% increase in the numbers of PWD nationwide each year.... Read More about Individualised screening for diabetic retinopathy: the ISDR study—rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening.
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., Wu, M., Brown, P., Boycott, N., Kaylor-Hughes, C., Morris, M., Rowley, E., Simpson, J., Smart, D., Stubley, M., Kai, J., & 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/s12916-019-1253-5Background: 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.