Skip to main content

Research Repository

Advanced Search

All Outputs (145)

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

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. (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, 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.

Lessons from the PROTECT-CH COVID-19 platform trial in care homes (2024)
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. (in press). Lessons from the PROTECT-CH COVID-19 platform trial in care homes. Health Technology Assessment,

Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT (2024)
Journal Article
Wyatt, L. A., Bradshaw, L. E., Brown, S. J., Haines, R. H., Montgomery, A. A., Perkin, M. R., Sach, T. H., Lawton, S., Flohr, C., Ridd, M. J., Chalmers, J. R., Brooks, J., Swinden, R., Mitchell, E. J., Tarr, S., Jay, N., Thomas, K. S., Allen, H., Cork, M. J., Kelleher, M. M., …Williams, H. C. (2024). Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT. Health Technology Assessment, 28(29), 1-116. https://doi.org/10.3310/rhdn9613

Background

Atopic eczema is a common childhood skin problem linked with asthma, food allergy and allergic rhinitis that impairs quality of life.

Objectives

To determine whether advising parents to apply daily emollients in the first year can... Read More about Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT.

Prevalence and risk factors for milk allergy overdiagnosis in the BEEP trial cohort (2024)
Journal Article
Allen, H. I., Wing, O., Milkova, D., Jackson, E., Li, K., Bradshaw, L. E., Wyatt, L., Haines, R., Santer, M., Murphy, A. W., Brown, S. J., Kelleher, M., Perkin, M. R., Jay, N., Smith, T. D. H., Moriarty, F., Montgomery, A. A., Williams, H. C., & Boyle, R. J. (2025). Prevalence and risk factors for milk allergy overdiagnosis in the BEEP trial cohort. Allergy, 80(1), 148-160. https://doi.org/10.1111/all.16203

Background: Cow's milk allergy (CMA) overdiagnosis in young children appears to be increasing and has not been well characterised. We used a clinical trial population to characterise CMA overdiagnosis and identify individual‐level and primary care pr... Read More about Prevalence and risk factors for milk allergy overdiagnosis in the BEEP trial cohort.

Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (Hand-2): study protocol for a randomised controlled trial (2024)
Journal Article
Harrison, S., Ogollah, R., Hollingworth, W., Mills, N., Karantana, A., Blazeby, J., Montgomery, A., Shafayat, A., Jarrett, H., & Davis, T. (2024). Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (Hand-2): study protocol for a randomised controlled trial. Trials, 25(1), Article 398. https://doi.org/10.1186/s13063-024-08003-1

Background: Dupuytren’s contractures (DC) are fibrous cords under the skin of the hand that cause one or more fingers to curl gradually and irreversibly towards the palm. These contractures are usually painless but can cause a loss of hand function.... Read More about Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (Hand-2): study protocol for a randomised controlled trial.

Choosing and evaluating randomisation methods in clinical trials: a qualitative study (2024)
Journal Article
Bruce, C. L., Iflaifel, M., Montgomery, A., Ogollah, R., Sprange, K., & Partlett, C. (2024). Choosing and evaluating randomisation methods in clinical trials: a qualitative study. Trials, 25(1), Article 199. https://doi.org/10.1186/s13063-024-08005-z

Background: There exist many different methods of allocating participants to treatment groups during a randomised controlled trial. Although there is research that explores trial characteristics that are associated with the choice of method, there is... Read More about Choosing and evaluating randomisation methods in clinical trials: a qualitative study.

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2024)
Journal Article
RECOVERY Collaborative Group, Sandercock, P., Darbyshire, J., DeMets, D., Fowler, R., Lalloo, D., Munavvar, M., Warris, A., Wittes, J., Cradduck-Bamford, A., Barton, J., Basoglu, A., Brown, R., Brudlo, W., Denis, E., Fletcher, L., Howard, S., Taylor, K., Cui, G., Goodenough, B., …Local Clinical Centre staff (for the RECOVERY Collaborative Group). (in press). Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Nature Communications, 15, Article 924. https://doi.org/10.1038/s41467-023-43644-x

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOV... Read More about Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

[TEMPORARILY RENAMED] Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial (2024)
Journal Article
Faust, S. N., Jones, C. E., Staplin, N., Whittaker, E., Jaki, T., Juszczak, E., Spata, E., Wan, M., Bamford, A., Dmitri, P., Finn, A., Furness, J., Ramanan, A. V., Gale, C., Cathie, K., Drysdale, S. B., Bernatoniene, J., Murray, C., Roehr, C. C., Fleming, P. F., …Haynes, R. (2024). [TEMPORARILY RENAMED] Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial. The Lancet Child & Adolescent Health,

Background

Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 (PIMS-TS), also known as multisystem inflammatory syndrome in children (MIS-C) emerged in April, 2020. The paediatric comparisons within the RECOVERY tri... Read More about [TEMPORARILY RENAMED] Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial.

Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial (2024)
Journal Article
RECOVERY Collaborative Group, Faust, S. N., Haynes, R., Jones, C. E., Staplin, N., Whittaker, E., Jaki, T., Juszczak, E., Spata, E., Wan, M., Bamford, A., Dimitri, P., Finn, A., Furness, J., Ramanan, A. V., Gale, C., & Montgomery, A. (2024). Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial. The Lancet Child & Adolescent Health, 8(3), 190-200. https://doi.org/10.1016/S2352-4642%2823%2900316-4

Background
Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 (PIMS-TS), also known as multisystem inflammatory syndrome in children (MIS-C) emerged in April, 2020. The paediatric comparisons within the RECOVERY trial... Read More about Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial.

Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement (2023)
Journal Article
Kahan, B. C., Hall, S. S., Beller, E. M., Birchenall, M., Chan, A.-W., Elbourne, D., Little, P., Fletcher, J., Golub, R. M., Goulao, B., Hopewell, S., Islam, N., Zwarenstein, M., Juszczak, E., & Montgomery, A. A. (2023). Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA Network Open, 330(21), 2106-2114. https://doi.org/10.1001/jama.2023.19793

Importance

Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique method... Read More about Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.

Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement (2023)
Journal Article
Kahan, B. C., Hall, S. S., Beller, E. M., Birchenall, M., Elbourne, D., Juszczak, E., Little, P., Fletcher, J., Golub, R. M., Goulao, B., Hopewell, S., Islam, N., Zwarenstein, M., Chan, A.-W., & Montgomery, A. A. (2023). Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement. JAMA Network Open, 6(12), Article e2346121. https://doi.org/10.1001/jamanetworkopen.2023.46121

Importance

Trial protocols outline a trial’s objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates... Read More about Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement.

Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs) (2023)
Journal Article
Madurasinghe, V. W., Knapp, P., Eldridge, S., Collier, D., Treweek, S., Rick, J., Graffy, J., Parker, A., Salisbury, C., Torgerson, D., Jolly, K., Sidhu, M. S., Fife-Schaw, C., Hull, M. A., Sprange, K., Brettell, E., Bhandari, S., Montgomery, A., & Bower, P. (2023). Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs). BMC Medicine, 21(1), Article 425. https://doi.org/10.1186/s12916-023-03081-5

Background: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the... Read More about Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs).

Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2023)
Journal Article
Horby, P. W., Staplin, N., Peto, L., Emberson, J. R., Mark Campbell, M., Pessoa-Amorim, G., Basnyat, B., Thwaites, L., van Doorn, R., Hamers, R. L., Nel, J., Amuasi, J., Rawal, M., Ghosh, D., Douse, J., Hamilton, F., Kerry, A., Thu-Ta, P., Widdrington, J., Green, C. A., …Landray, M. J. (2023). Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Diabetes and Endocrinology, 11(12), 905-914. https://doi.org/10.1016/s2213-8587%2823%2900253-x

Background

Empagliflozin has been proposed as a treatment for COVID-19 on the basis of its anti-inflammatory, metabolic, and haemodynamic effects. The RECOVERY trial aimed to assess its safety and efficacy in patients admitted to hospital with COV... Read More about Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Emollients for preventing atopic eczema: Cost‐effectiveness analysis of the BEEP trial (2023)
Journal Article
Sach, T. H., Lartey, S. T., Davies, C., Chalmers, J. R., Haines, R. H., Bradshaw, L. E., Montgomery, A. A., Thomas, K. S., Brown, S. J., Ridd, M. J., Lawton, S., Cork, M. J., Flohr, C., Mitchell, E., Swinden, R., Wyatt, L., Tarr, S., Davies‐Jones, S., Jay, N., Kelleher, M. M., …the BEEP Study Team. (2023). Emollients for preventing atopic eczema: Cost‐effectiveness analysis of the BEEP trial. Clinical and Experimental Allergy, 53(10), 1011-1019. https://doi.org/10.1111/cea.14381

Background
Recent discoveries have led to the suggestion that enhancing skin barrier from birth might prevent eczema and food allergy.

Objective
To determine the cost‐effectiveness of daily all‐over‐body application of emollient during the firs... Read More about Emollients for preventing atopic eczema: Cost‐effectiveness analysis of the BEEP 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/s41598-023-38474-2

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.

Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease: The Lacunar Intervention Trial-2 (LACI-2) Randomized Clinical Trial (2023)
Journal Article
Wardlaw, J. M., Woodhouse, L. J., Mhlanga, I. I., Oatey, K., Heye, A. K., Bamford, J., Cvoro, V., Doubal, F. N., England, T., Hassan, A., Montgomery, A., O’Brien, J. T., Roffe, C., Sprigg, N., Werring, D. J., & Bath, P. M. (2023). Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease: The Lacunar Intervention Trial-2 (LACI-2) Randomized Clinical Trial. JAMA Neurology, 80(7), 682-692. https://doi.org/10.1001/jamaneurol.2023.1526

Importance Cerebral small vessel disease (cSVD) is a common cause of stroke (lacunar stroke), is the most common cause of vascular cognitive impairment, and impairs mobility and mood but has no specific treatment.

Objective To test the feasibili... Read More about Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease: The Lacunar Intervention Trial-2 (LACI-2) Randomized Clinical Trial.

Higher dose corticosteroids in patients admitted to hospital with COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial (2023)
Journal Article
Horby, P. W., Emberson, J. R., Basnyat, B., Campbell, M., Peto, L., Pessoa-Amorim, G., Staplin, N., Hamers, R. L., Amuasi, J., Nel, J., Kestelyn, E., Rawal, M., Kumar Jha, R., Thanh Phong, N., Sumardi, U., Paudel, D., Ngoc Thach, P., Nasronudin, N., Stratton, E., Mew, L., …RECOVERY Collaborative Group, R. C. G. (2023). Higher dose corticosteroids in patients admitted to hospital with COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 401(10387), 1499-1507. https://doi.org/10.1016/S0140-6736%2823%2900510-X

Background: Low-dose corticosteroids have been shown to reduce mortality for patients with COVID-19 requiring oxygen or ventilatory support (non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation)... Read More about Higher dose corticosteroids in patients admitted to hospital with COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial.