Outputs (397)

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

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, 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.

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.

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).

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,

Umbilical cord management in newborn resuscitation (2024)
Journal Article
Dorling, J. S., Roehr, C. C., Katheria, A. C., & Mitchell, E. J. (2024). Umbilical cord management in newborn resuscitation. Pediatric Research, https://doi.org/10.1038/s41390-024-03711-5

At birth, blood continues to flow from the mother to baby through the intact umbilical cord. This continuum of fetal-placental circulation, now taking place between the placenta and the newborn infant has been termed ‘placental transfusion’, and it e... Read More about Umbilical cord management in newborn resuscitation.

The acceptability of implementation of group B Streptococcus testing: Perspectives from women and health professionals in the GBS3 trial: A qualitative study (2024)
Journal Article
Constantinou, G., Ayers, S., Mitchell, E. J., Walker, K. F., Downe, S., Jones, A.-M., Moore, S., & Daniels, J. P. (2024). The acceptability of implementation of group B Streptococcus testing: Perspectives from women and health professionals in the GBS3 trial: A qualitative study. Women and Birth, 37(6), Article 101832. https://doi.org/10.1016/j.wombi.2024.101832

Objective: To determine the acceptability of different methods of routine testing for group B Streptococcus (GBS) colonisation to pregnant women and health care professionals (HCPs), and to examine barriers and facilitators to their implementation. D... Read More about The acceptability of implementation of group B Streptococcus testing: Perspectives from women and health professionals in the GBS3 trial: A qualitative study.