All Outputs (440)

The legacy effect of early HbA1c control on microvascular complications and hospital admissions in type 2 diabetes: findings from a large UK study (2025)
Journal Article
Aldafas, R., Vinogradova, Y., Crabtree, T. S. J., Gordon, J., & Idris, I. (2025). The legacy effect of early HbA1c control on microvascular complications and hospital admissions in type 2 diabetes: findings from a large UK study. Therapeutic Advances in Endocrinology and Metabolism, https://doi.org/10.1177/20420188251350897

Introduction
There is conflicting evidence regarding optimal glycaemic targets to reflect the legacy effect of hyperglycaemia in people with type 2 diabetes (T2D). We examined the risks of microvascular complications and hospital admission with HbA... Read More about The legacy effect of early HbA1c control on microvascular complications and hospital admissions in type 2 diabetes: findings from a large UK study.

The PD COMM process evaluation: describing interventions and implementation in a UK pragmatic randomised controlled trial of speech and language therapy for people with Parkinson’s-related dysarthria (2025)
Journal Article
Nicoll, A., Brady, M. C., Masterson-Algar, P., Burton, C., Beaton, G., Dickson, S., Caulfield, M., Smith, C. H., Clarke, C. E., Ives, N., Jowett, S., Rick, C., Woolley, R., Sackley, C. M., & On behalf of the PD COMM Collaborative group. (in press). The PD COMM process evaluation: describing interventions and implementation in a UK pragmatic randomised controlled trial of speech and language therapy for people with Parkinson’s-related dysarthria. International Journal of Language & Communication Disorders,

Clinical and cost effectiveness of a standardised diagnostic assessment for children and adolescents with emotional difficulties: the STADIA multi-centre RCT (2025)
Journal Article
Sayal, K., Wyatt, L., Thomson, L., Holt, G., Ewart, C., Bhardwaj, A., Dubicka, B., Marshall, T., Gledhill, J., Lang, A., Sprange, K., Partlett, C., Newman, K., Moody, S., Bould, H., Upton, C., Keane, M., Cox, E., James, M., & Montgomery, A. (in press). Clinical and cost effectiveness of a standardised diagnostic assessment for children and adolescents with emotional difficulties: the STADIA multi-centre RCT. Health Technology Assessment,

Comparison of the Diagnostic Performance of the Central Vein Sign and CSF Oligoclonal Bands Supporting the Diagnosis of Multiple Sclerosis (2025)
Journal Article
Allen, C. M., Clarke, M. A., Pai, H. V., Cauchi, M., Hawken, J., Htet, Z. M., Allen-Philbey, K., Mohamed, B., Fitzsimmons, D., Das Nair, R., Morgan, P., Partlett, C., Dineen, R. A., Schmierer, K., Tallantyre, E. C., & Evangelou, N. (2025). Comparison of the Diagnostic Performance of the Central Vein Sign and CSF Oligoclonal Bands Supporting the Diagnosis of Multiple Sclerosis. Neurology Open Access, 1(2), Article e000017. https://doi.org/10.1212/WN9.0000000000000017

Background and Objectives
The central vein sign (CVS) describes the presence of venules within multiple sclerosis (MS) brain lesions, visible on T2*-weighted MRI. In the upcoming revision of the MS diagnostic criteria, the simplified “rule of 6” (i.... Read More about Comparison of the Diagnostic Performance of the Central Vein Sign and CSF Oligoclonal Bands Supporting the Diagnosis of Multiple Sclerosis.

Molnupiravir or nirmatrelvir–ritonavir plus usual care versus usual care alone in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2025)
Journal Article
Horby, P. W., Staplin, N., Peto, L., Emberson, J. R., Campbell, M., Pessoa-Amorim, G., Basnyat, B., Thwaites, L., van Doorn, R., Hamers, R. L., Nel, J., Amuasi, J., Stewart, R., Ghosh, D., Blencowe, N., Desai, P., Easom, N., Majumdar, J., Hine, P., Chadwick, D., …Wittes, J. (2025). Molnupiravir or nirmatrelvir–ritonavir plus usual care versus usual care alone in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Infectious Diseases, https://doi.org/10.1016/S1473-3099%2825%2900093-3

Background
Molnupiravir and nirmatrelvir–ritonavir are oral antivirals that have shown efficacy in preventing disease progression in outpatients with COVID-19. We aimed to evaluate these treatments for patients hospitalised with COVID-19 pneumonia,... Read More about Molnupiravir or nirmatrelvir–ritonavir plus usual care versus usual care alone in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

AI interventions in cancer screening: balancing equity and cost-effectiveness (2025)
Journal Article
Roadevin, C., & Hill, H. (2025). AI interventions in cancer screening: balancing equity and cost-effectiveness. Journal of Medical Ethics, Article jme-2025-110707. https://doi.org/10.1136/jme-2025-110707

This paper examines the integration of artificial intelligence (AI) into cancer screening programmes, focusing on the associated equity challenges and resource allocation implications. While AI technologies promise significant benefits—such as improv... Read More about AI interventions in cancer screening: balancing equity and cost-effectiveness.

Dog-assisted interventions for children and adults with mental health or neurodevelopmental conditions: systematic review (2025)
Journal Article
Shoesmith, E., Hall, S., Sowden, A., Stevens, H., Pervin, J., Riga, J., McMillan, D., Mills, D., Clarke, C., Wu, Q., Gibsone, S., & Ratschen, E. (2025). Dog-assisted interventions for children and adults with mental health or neurodevelopmental conditions: systematic review. British Journal of Psychiatry, 1-14. https://doi.org/10.1192/bjp.2025.8

Background

Dog-assisted interventions (DAIs) to improve health-related outcomes for people with mental health or neurodevelopmental conditions are becoming increasingly popular. However, DAIs are not based on robust scientific evidence.

Aims... Read More about Dog-assisted interventions for children and adults with mental health or neurodevelopmental conditions: systematic review.

Lessons from the PROTECT-CH COVID-19 platform trial in care homes (2025)
Journal Article
Bath, P. M., Ball, J., Boyd, M., Gage, H., Glover, M., Godfrey, M., Guthrie, B., Hewitt, J., Howard, R., Jaki, T., Juszczak, E., Lasserson, D., Leighton, P., Leyland, V., Shen Lim, W., Logan, P., Meakin, G., Montgomery, A., Ogollah, R., Passmore, P., …Gordon, A. L. (2025). Lessons from the PROTECT-CH COVID-19 platform trial in care homes. Health Technology Assessment, https://doi.org/10.3310/MTRS8833

Background
Coronavirus disease-2019 was associated with significant mortality and morbidity in care homes in 2020–1. Repurposed antiviral drugs might reduce morbidity and mortality through reducing viral transmission, infection, replication and infl... Read More about Lessons from the PROTECT-CH COVID-19 platform trial in care homes.

Barriers and facilitators to using standardised diagnostic assessments in child and adolescent mental health services: a qualitative process evaluation of the STADIA trial (2025)
Journal Article
Thomson, L., Newman, K., Ewart, C., Bhardwaj, A., Dubicka, B., Marshall, T., Gledhill, J., Lang, A., Sprange, K., & Sayal, K. (2025). Barriers and facilitators to using standardised diagnostic assessments in child and adolescent mental health services: a qualitative process evaluation of the STADIA trial. European Child and Adolescent Psychiatry, https://doi.org/10.1007/s00787-025-02678-w

Background: The STADIA trial aimed to assess the effectiveness of a standardised diagnostic assessment tool (Development and Wellbeing Assessment, DAWBA) in aiding clinician-made diagnosis decisions in Child and Adolescent Mental Health Services (CAM... Read More about Barriers and facilitators to using standardised diagnostic assessments in child and adolescent mental health services: a qualitative process evaluation of the STADIA trial.

Developing an adaptive platform trial for evaluation of medical treatments for Crohn’s disease (2025)
Journal Article
Noor, N. M., Radford, S. J., Choodari-Oskooei, B., Gordon, M., Hart, A. L., Hepburn, T., Juszczak, E., Lindsay, J. O., Kennedy, N. A., Parmar, M. K. B., Jairath, V., & Moran, G. W. (2025). Developing an adaptive platform trial for evaluation of medical treatments for Crohn’s disease. Nature Reviews Gastroenterology and Hepatology, 22, 364-366. https://doi.org/10.1038/s41575-025-01052-0

There is emerging interest in adaptive platform trials for inflammatory bowel disease. In this Comment, we present the results of a workshop that was convened to consider the opportunities and challenges of developing a platform trial in Crohn’s dise... Read More about Developing an adaptive platform trial for evaluation of medical treatments for Crohn’s disease.

Mixed-methods study to develop extensions to the SPIRIT and CONSORT statements for factorial randomised trials: the Reporting Factorial Trials (RAFT) study (2025)
Journal Article
Hall, S. S., Juszczak, E., Birchenall, M., Elbourne, D., Beller, E., Chan, A.-W., Little, P., Montgomery, A. A., & Kahan, B. C. (2025). Mixed-methods study to develop extensions to the SPIRIT and CONSORT statements for factorial randomised trials: the Reporting Factorial Trials (RAFT) study. BMJ Open, 15(2), Article e082917. https://doi.org/10.1136/bmjopen-2023-082917

Background Extensions to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) reporting recommendations specifically for factorial trials have been developed by the Repor... Read More about Mixed-methods study to develop extensions to the SPIRIT and CONSORT statements for factorial randomised trials: the Reporting Factorial Trials (RAFT) study.

Higher dose corticosteroids in hospitalised COVID-19 patients requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial (2025)
Journal Article
Horby, P. W., Emberson, J. R., Thwaites, L., Campbell, M., Peto, L., Pessoa-Amorim, G., Staplin, N., Hamers, R. L., Amuasi, J., Nel, J., Kestelyn, E., Thanh Phong, N., Shrestha, A., Nasronudin, N., Sarkar, R., Ngoc Thach, P., Paudel, D., Sumardi, U., Stewart, R., Nelwan, E., …Landray, M. J. (2025). Higher dose corticosteroids in hospitalised COVID-19 patients requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial. eClinicalMedicine, 81, Article 103080. https://doi.org/10.1016/j.eclinm.2025.103080

Background
Low dose corticosteroids (e.g., 6 mg dexamethasone) have been shown to reduce mortality for hypoxic COVID-19 patients. We have previously reported that higher dose corticosteroids cause harm in patients with clinical hypoxia but not recei... Read More about Higher dose corticosteroids in hospitalised COVID-19 patients requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial.

Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions (2025)
Journal Article
Kahan, B. C., Juszczak, E., Beller, E., Birchenall, M., Chan, A.-W., Hall, S., Little, P., Fletcher, J., Golub, R. M., Goulao, B., Hopewell, S., Islam, N., Zwarenstein, M., Elbourne, D., & Montgomery, A. (2025). Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions. BMJ, 388, Article e080785. https://doi.org/10.1136/bmj-2024-080785

This report presents the explanation and elaboration paper for the CONSORT (Consolidated Standards of Reporting Trials) 2010 and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 extensions for factorial trials. Factori... Read More about Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions.

Sotrovimab versus usual care in patients admitted to hospital with COVID-19: a randomised, controlled, open-label, platform trial (RECOVERY) (2025)
Preprint / Working Paper
Horby, P. W., Emberson, J. R., Peto, L., Staplin, N., Campbell, M., Pessoa-Amorim, G., Stewart, R., Ghosh, D., Cooke, G., Blencowe, N., Moreno-Cuesta, J., Desai, P., Hine, P., Underwood, J., Easom, N., Majumdar, J., Bhagani, S., Baillie, J. K., Buch, M. H., Faust, S. N., …Group RECOVERY Collaborative. (2025). Sotrovimab versus usual care in patients admitted to hospital with COVID-19: a randomised, controlled, open-label, platform trial (RECOVERY)

Background Sotrovimab is a neutralising monoclonal antibody that has been proposed as a treatment for patients admitted to hospital with COVID-19.

Methods In this randomised, controlled, open-label platform trial, several possible treatments were... Read More about Sotrovimab versus usual care in patients admitted to hospital with COVID-19: a randomised, controlled, open-label, platform trial (RECOVERY).

Evaluating the Cost‐Effectiveness of Antenatal Screening for Major Structural Anomalies During the First Trimester of Pregnancy: A Decision Model (2025)
Journal Article
Campbell, H. E., Karim, J. N., Papageorghiou, A. T., Wilson, E. C., Rivero-Arias, O., & ACCEPTS Study. (2025). Evaluating the Cost‐Effectiveness of Antenatal Screening for Major Structural Anomalies During the First Trimester of Pregnancy: A Decision Model. BJOG: An International Journal of Obstetrics and Gynaecology, 132(5), 638-647. https://doi.org/10.1111/1471-0528.18053

Objective: To assess the cost-effectiveness of modifying current antenatal screening by adding first trimester structural anomaly screening to standard of care second trimester anomaly screening.

Design: Health economic decision model. Setting: N... Read More about Evaluating the Cost‐Effectiveness of Antenatal Screening for Major Structural Anomalies During the First Trimester of Pregnancy: A Decision Model.

Developing generic clinical trial animated explainer videos in the UK: results of a survey and case study (2025)
Journal Article
Calvert, C., Barber, V. S., Appelbe, D., Sprange, K., Nollett, C., Lugg-Widger, F., Tanner, S., & Richards, D. B. (2025). Developing generic clinical trial animated explainer videos in the UK: results of a survey and case study. Trials, 26(1), Article 25. https://doi.org/10.1186/s13063-024-08687-5

BACKGROUND: Animated short videos used to explain a concept or project are often called animated explainer videos (AEVs). AEVs can supplement or provide an alternative to participant information sheets as a means of giving information about clinical... Read More about Developing generic clinical trial animated explainer videos in the UK: results of a survey and case study.

Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment: the PrAISED research programme, including a randomised controlled trial (2025)
Journal Article
Harwood, R. H., Goldberg, S. E., van Der Wardt, V., Brand, A., Booth, V., Di Lorito, C., Hoare, Z., Hancox, J., Bajwa, R., Burgon, C., Howe, L., Cowley, A., Bramley, T., Long, A., Lock, J., Bosco, A., Tucker, R., Robertson, K., Ward, M., Ward, A., …Masud, T. (in press). Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment: the PrAISED research programme, including a randomised controlled trial. Programme Grants for Applied Research, https://doi.org/10.3310/PLNV0118

Background
Hidradenitis suppurativa (HS) is a long-term skin condition where evidence for management after first-line treatment fails is limited and practice varies across the UK. Medical and surgical treatment options are potential avenues of treat... Read More about Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment: the PrAISED research programme, including a randomised controlled trial.

The clinical and cost effectiveness of a STAndardised DIagnostic Assessment for children and adolescents with emotional difficulties (STADIA); multi- centre randomised controlled trial (2025)
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. (2025). 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, 66(6), 805-820. https://doi.org/10.1111/jcpp.14090

Background

Standardised Diagnostic Assessment tools, such as the Development and Well-Being Assessment (DAWBA), may aid detection and diagnosis of emotional disorders but there is limited real-world evidence of their clinical or cost effectiveness... Read More about The clinical and cost effectiveness of a STAndardised DIagnostic Assessment for children and adolescents with emotional difficulties (STADIA); multi- centre randomised controlled trial.

Strategies to improve recruitment in mental health clinical trials: a scoping review (RE-MIND study) (2024)
Journal Article
Iflaifel, M., Hall, C. L., Green, H. R., Willis, A., Rennick-Egglestone, S., Juszczak, E., Townsend, M., Martin, J., & Sprange, K. (2024). Strategies to improve recruitment in mental health clinical trials: a scoping review (RE-MIND study). Trials, 25(1), Article 832. https://doi.org/10.1186/s13063-024-08665-x

Background: Lower than expected recruitment continues to be one of the major causes of trial delays, and trials to improve mental health are no exception. Indeed, recruitment challenges in trials of vulnerable populations, such as those living with m... Read More about Strategies to improve recruitment in mental health clinical trials: a scoping review (RE-MIND study).

Cost-effectiveness of long-acting progestogens versus the combined oral contraceptives pill for preventing recurrence of endometriosis-related pain following surgery: an economic evaluation alongside the PRE-EMPT trial (2024)
Journal Article
Melyda, M., Monahan, M., Cooper, K. G., Bhattacharya, S., Daniels, J. P., Cheed, V., Middleton, L., & Roberts, T. E. (2024). Cost-effectiveness of long-acting progestogens versus the combined oral contraceptives pill for preventing recurrence of endometriosis-related pain following surgery: an economic evaluation alongside the PRE-EMPT trial. BMJ Open, 14(12), Article e088072. https://doi.org/10.1136/bmjopen-2024-088072

Objectives

To evaluate the cost-effectiveness of long-acting progestogens (LAP), including levonorgestrel-releasing intrauterine system (LNG-IUS) and depot-medroxyprogesterone acetate (DMPA), compared with the combined oral contraceptives pill (C... Read More about Cost-effectiveness of long-acting progestogens versus the combined oral contraceptives pill for preventing recurrence of endometriosis-related pain following surgery: an economic evaluation alongside the PRE-EMPT trial.