Outputs (116)

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.

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.

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.

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.

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.

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).