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
Professor ED JUSZCZAK's Outputs (82)
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/10.1111/1471-0528.18053Objective: 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.
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-xBackground: 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,
Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the 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). Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study. Trials, 25, Article 596. https://doi.org/10.1186/s13063-024-08435-9Background: Ensuring diversity in clinical trials can be a challenge, which may be exacerbated when recruiting vulnerable populations, such as participants with mental health illness. As recruitment continues to be the major cause of trial delays, re... Read More about Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study.
Detection of non-cardiac fetal abnormalities on ultrasound at 11–14 weeks: systematic review and meta-analysis (2024)
Journal Article
Karim, J. N., Di Mascio, D., Roberts, N., Papageorghiou, A. T., Alfirevic, Z., Chudleigh, T., Goodman, H., Ioannou, C., Longworth, H., Karim, J., Nicolaides, K., Pandya, P., Smith, G., Thilaganathan, B., Thornton, J., Rivero-Arias, O., Campbell, H., Juszczak, E., Linsell, L., Wilson, E., …Yaz, G. (2024). Detection of non-cardiac fetal abnormalities on ultrasound at 11–14 weeks: systematic review and meta-analysis. Ultrasound in Obstetrics and Gynaecology, 64(1), 15-27. https://doi.org/10.1002/uog.27649Objectives: To assess the diagnostic accuracy of two-dimensional ultrasound at 11–14 weeks' gestation as a screening test for individual fetal anomalies and to identify factors impacting on screening performance. Methods: This was a systematic review... Read More about Detection of non-cardiac fetal abnormalities on ultrasound at 11–14 weeks: systematic review and meta-analysis.
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-xDimethyl 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.
Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen (2024)
Journal Article
Gupta, S., Subhedar, N. V., Bell, J. L., Field, D., Bowler, U., Hutchison, E., Johnson, S., Kelsall, W., Pepperell, J., Roberts, T., Sinha, S., Stanbury, K., Wyllie, J., Hardy, P., Juszczak, E., & Baby-OSCAR Collaborative Group, B.-O. C. G. (2024). Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen. New England Journal of Medicine, 390(4), 314-325. https://doi.org/10.1056/NEJMoa2305582BACKGROUND: The cyclooxygenase inhibitor ibuprofen may be used to treat patent ductus arteriosus (PDA) in preterm infants. Whether selective early treatment of large PDAs with ibuprofen would improve short-term outcomes is not known. METHODS: We cond... Read More about Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.
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%2900316-4Background
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.
[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.
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.2023.46121Importance
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.2023.19793Importance
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.
Techniques to increase lumbar puncture success in newborn babies: the NeoCLEAR RCT (2023)
Journal Article
Roehr, C. C., Marshall, A. S., Scrivens, A., Sadarangani, M., Williams, R., Yong, J., Linsell, L., Chiocchia, V., Bell, J. L., Stokes, C., Santhanadass, P., Nicoll, I., Adams, E., King, A., Murray, D., Bowler, U., Stanbury, K., & Juszczak, E. (2023). Techniques to increase lumbar puncture success in newborn babies: the NeoCLEAR RCT. Health Technology Assessment, 27(33), 1-97. https://doi.org/10.3310/THJY0671Background:
Lumbar puncture is an essential tool for diagnosing meningitis. Neonatal lumbar puncture, although frequently performed, has low success rates (50-60%). Standard technique includes lying infants on their side and removing the stylet '... Read More about Techniques to increase lumbar puncture success in newborn babies: the NeoCLEAR RCT.
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials (2023)
Journal Article
Gamble, C., Lewis, S., Stocken, D., Juszczak, E., Bradburn, M., Doré, C., & Kean, S. (2024). Determining a risk-proportionate approach to the validation of statistical programming for clinical trials. Clinical Trials, 21(1), 85-94. https://doi.org/10.1177/17407745231204036Background
The contribution of the statistician to the design and analysis of a clinical trial is acknowledged as essential. Ability to reconstruct the statistical contribution to a trial requires rigorous and transparent documentation as evidenced... Read More about Determining a risk-proportionate approach to the validation of statistical programming for clinical trials.
2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheterisation: the ARCTIC randomised controlled feasibility trial (2023)
Journal Article
Clarke, P., Soe, A., Nichols, A., Harizaj, H., Webber, M. A., Linsell, L., Bell, J. L., Tremlett, C., Muthukumar, P., Pattnayak, S., Partlett, C., King, A., Juszczak, E., & Heath, P. T. (2023). 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheterisation: the ARCTIC randomised controlled feasibility trial. Archives of Disease in Childhood. Fetal and Neonatal Edition, https://doi.org/10.1136/archdischild-2023-325871Objective: Catheter-related sepsis (CRS) is a major complication with significant morbidity and mortality. Evidence is lacking regarding the most appropriate antiseptic for skin disinfection before percutaneous central venous catheter (PCVC) insertio... Read More about 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheterisation: the ARCTIC randomised controlled feasibility trial.
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-xBackground
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.
Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study (2023)
Journal Article
Iflaifel, M., Hall, C. L., Green, H. R., Willis, A., Rennick-Egglestone, S., Juszczak, E., Townsend, M., Martin, J., & Sprange, K. (2023). Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study. BMC Medical Research Methodology, 23(1), Article 211. https://doi.org/10.1186/s12874-023-02032-1Background:
Barriers to mental health research participation are well documented including distrust of services and research; and stigma surrounding mental health. They can contribute to a lack of diversity amongst participants in mental health r... Read More about Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study.
Frenotomy with breastfeeding support versus breastfeeding support alone for infants with tongue-tie and breastfeeding difficulties: the FROSTTIE RCT (2023)
Journal Article
Knight, M., Ramakrishnan, R., Ratushnyak, S., Rivero-Arias, O., Bell, J., Bowler, U., Buchanan, P., Carter, C., Cole, C., Hewer, O., Hurd, M., King, A., Juszczak, E., Linsell, L., Long, A. M., Mottram, L., Murray, D., Oddie, S., Quigley, M., Stalker, V., …Hardy, P. (2023). Frenotomy with breastfeeding support versus breastfeeding support alone for infants with tongue-tie and breastfeeding difficulties: the FROSTTIE RCT. Health Technology Assessment, 27(11), 1-73. https://doi.org/10.3310/WBBW2302Background
Tongue-tie can be diagnosed in 3–11% of babies, with some studies reporting almost universal breastfeeding difficulties, and others reporting very few feeding difficulties that relate to the tongue-tie itself, instead noting that incorrec... Read More about Frenotomy with breastfeeding support versus breastfeeding support alone for infants with tongue-tie and breastfeeding difficulties: the FROSTTIE RCT.
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-XBackground: 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.
Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study (2023)
Journal Article
Iflaifel, M., Sprange, K., Bell, J., Cook, A., Gamble, C., Julious, S. A., Juszczak, E., Linsell, L., Montgomery, A., & Partlett, C. (2023). Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study. Trials, 24, Article 71. https://doi.org/10.1186/s13063-022-06992-5Background: Existing guidelines recommend statisticians remain blinded to treatment allocation prior to the final analysis and that any interim analyses should be conducted by a separate team from the one undertaking the final analysis. However, ther... Read More about Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study.