Professor ED JUSZCZAK's Outputs (84)

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.

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/s13063-022-06992-5

Background: 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.

A systematic review of randomisation method use in RCTs and association of trial design characteristics with method selection (2022)
Journal Article
Bruce, C. L., Juszczak, E., Ogollah, R., Partlett, C., & Montgomery, A. (2022). A systematic review of randomisation method use in RCTs and association of trial design characteristics with method selection. BMC Medical Research Methodology, 22(1), Article 314. https://doi.org/10.1186/s12874-022-01786-4

Background: When conducting a randomised controlled trial, there exist many different methods to allocate participants, and a vast array of evidence-based opinions on which methods are the most effective at doing this, leading to differing use of the... Read More about A systematic review of randomisation method use in RCTs and association of trial design characteristics with method selection.

Planned delivery for pre-eclampsia between 34 and 37 weeks of gestation: the PHOENIX RCT (2022)
Journal Article
Chappell, L. C., Brocklehurst, P., Green, M., Hardy, P., Hunter, R., Beardmore-Gray, A., Bowler, U., Brockbank, A., Chiocchia, V., Cox, A., Duhig, K., Fleminger, J., Gill, C., Greenland, M., Hendy, E., Kennedy, A., Leeson, P., Linsell, L., McCarthy, F. P., O’Driscoll, J., …Shennan, A. (2022). Planned delivery for pre-eclampsia between 34 and 37 weeks of gestation: the PHOENIX RCT. Health Technology Assessment, https://doi.org/10.3310/CWWH0622

In women with late preterm pre-eclampsia (i.e. at 34 to 36 weeks' gestation), the optimal delivery time is unclear because limitation of maternal-fetal disease progression needs to be balanced against infant complications. The aim of this trial was... Read More about Planned delivery for pre-eclampsia between 34 and 37 weeks of gestation: the PHOENIX RCT.

Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR): an open-label, 2 × 2 factorial, randomised, controlled trial (2022)
Journal Article
Marshall, A. S. J., Scrivens, A., Bell, J. L., Linsell, L., Hardy, P., Yong, J., Williams, R., Adams, E., Sadarangani, M., Juszczak, E., Roehr, C. C., & NeoCLEAR Collaborative Group. (2023). Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR): an open-label, 2 × 2 factorial, randomised, controlled trial. The Lancet Child & Adolescent Health, 7(2), 91-100. https://doi.org/10.1016/s2352-4642%2822%2900343-1

Background
Newborn infants are the highest-risk age group for bacterial meningitis. Lumbar punctures are therefore frequently performed in neonates, but success rates are low (50-60%). In Neonatal Champagne Lumbar punctures Every time-A Randomised C... Read More about Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR): an open-label, 2 × 2 factorial, randomised, controlled trial.

Mechanisms affecting the gut of preterm infants in enteral feeding trials: A nested cohort within a randomised controlled trial of lactoferrin (2022)
Journal Article
Young, G. R., Berrington, J. E., Cummings, S., Dorling, J., Ewer, A. K., Frau, A., Lett, L., Probert, C., Juszczak, E., Kirby, J., Beck, L. C., Renwick, V. L., Lamb, C. A., Lanyon, C., McGuire, W., Stewart, C. J., & Embleton, N. D. (2023). Mechanisms affecting the gut of preterm infants in enteral feeding trials: A nested cohort within a randomised controlled trial of lactoferrin. Archives of Disease in Childhood. Fetal and Neonatal Edition, 108(3), 272-279. https://doi.org/10.1136/archdischild-2022-324477

Objective: To determine the impact of supplemental bovine lactoferrin on the gut microbiome and metabolome of preterm infants.

Design: Cohort study nested within a randomised controlled trial (RCT). Infants across different trial arms were matched... Read More about Mechanisms affecting the gut of preterm infants in enteral feeding trials: A nested cohort within a randomised controlled trial of lactoferrin.

Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis (2022)
Journal Article
RECOVERY Collaborative Group, Horby, P. W., Emberson, J. R., Mafham, M., Campbell, M., Peto, L., Pessoa-Amorim, G., Spata, E., Staplin, N., Lowe, C., Chadwick, D. R., Brightling, C., Stewart, R., Collini, P., Ashish, A., Green, C. A., Prudon, B., Felton, T., Kerry, A., Baillie, J. K., …Landray, M. J. (2022). Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis. Lancet, 400(10349), 359-368. https://doi.org/10.1016/S0140-6736%2822%2901109-6

Background: We aimed to evaluate the use of baricitinib, a Janus kinase (JAK) 1–2 inhibitor, for the treatment of patients admitted to hospital with COVID-19. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of... Read More about Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis.

Cost-Utility Analysis of Planned Early Delivery or Expectant Management for Late Preterm Pre-eclampsia (PHOENIX) (2022)
Journal Article
Hunter, R., Beardmore-Gray, A., Greenland, M., Linsell, L., Juszczak, E., Hardy, P., Placzek, A., Shennan, A., Marlow, N., Chappell, L. C., & PHOENIX Study Group. (2022). Cost-Utility Analysis of Planned Early Delivery or Expectant Management for Late Preterm Pre-eclampsia (PHOENIX). PharmacoEconomics - Open, 6(5), 723-733. https://doi.org/10.1007/s41669-022-00355-1

Aim: There is currently limited evidence on the costs associated with late preterm pre-eclampsia beyond antenatal care and post-natal discharge from hospital. The aim of this analysis is to evaluate the 24-month cost-utility of planned delivery for w... Read More about Cost-Utility Analysis of Planned Early Delivery or Expectant Management for Late Preterm Pre-eclampsia (PHOENIX).

Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units (2022)
Journal Article
Iflaifel, M., Partlett, C., Bell, J., Cook, A., Gamble, C., Julious, S., Juszczak, E., Linsell, L., Montgomery, A., & Sprange, K. (2022). Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units. Trials, 23(1), Article 535. https://doi.org/10.1186/s13063-022-06481-9

Background: Blinding is an established approach in clinical trials which aims to minimise the risk of performance and detection bias. There is little empirical evidence to guide UK clinical trials units (CTUs) about the practice of blinding statistic... Read More about Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units.

Two-year follow-up of infant and maternal outcomes after planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): A randomised controlled trial (2022)
Journal Article
Beardmore-Gray, A., Greenland, M., Linsell, L., Juszczak, E., Hardy, P., Placzek, A., Hunter, R., Sparkes, J., Green, M., Shennan, A., Marlow, N., Chappell, L. C., & the PHOENIX Study Group. (2022). Two-year follow-up of infant and maternal outcomes after planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): A randomised controlled trial. BJOG: An International Journal of Obstetrics and Gynaecology, 129(10), 1654-1663. https://doi.org/10.1111/1471-0528.17167

Objective: We evaluated the best time to initiate delivery in late preterm pre-eclampsia in order to optimise long-term infant and maternal outcomes. Design: Parallel-group, non-masked, randomised controlled trial. Setting: Forty-six maternity units... Read More about Two-year follow-up of infant and maternal outcomes after planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): A randomised controlled trial.

Transfer of thawed frozen embryo versus fresh embryo to improve the healthy baby rate in women undergoing IVF: the E-Freeze RCT (2022)
Journal Article
Maheshwari, A., Bari, V., Bell, J. L., Bhattacharya, S., Bhide, P., Bowler, U., Brison, D., Child, T., Chong, H. Y., Cheong, Y., Cole, C., Coomarasamy, A., Cutting, R., Goodgame, F., Hardy, P., Hamoda, H., Juszczak, E., Khalaf, Y., King, A., Kurinczuk, J. J., …Troup, S. (2022). Transfer of thawed frozen embryo versus fresh embryo to improve the healthy baby rate in women undergoing IVF: the E-Freeze RCT. Health Technology Assessment, 26(25), 1-142. https://doi.org/10.3310/AEFU1104

Background
Freezing all embryos, followed by thawing and transferring them into the uterine cavity at a later stage (freeze-all), instead of fresh-embryo transfer may lead to improved pregnancy rates and fewer complications during in vitro fertilisa... Read More about Transfer of thawed frozen embryo versus fresh embryo to improve the healthy baby rate in women undergoing IVF: the E-Freeze RCT.

The COVID-19 pandemic has highlighted the need to invest in care home research infrastructure (2022)
Journal Article
Gordon, A. L., Rick, C., Juszczak, E., Montgomery, A., Howard, R., Guthrie, B., Lim, W. S., Shenkin, S., Leighton, P., Bath, P. M., Ball, J., Gage, H., Glover, M., Godfrey, M., Hewitt, J., Jaki, T., Lasserson, D., Logan, P., Passmore, P., Quinlan, P., …Tate, V. (2022). The COVID-19 pandemic has highlighted the need to invest in care home research infrastructure. Age and Ageing, 51(3), Article afac052. https://doi.org/10.1093/ageing/afac052

The COVID-19 pandemic resulted in catastrophic levels of morbidity and mortality for care home residents. Despite this, research platforms for COVID-19 in care homes arrived late in the pandemic compared with other care settings. The Prophylactic The... Read More about The COVID-19 pandemic has highlighted the need to invest in care home research infrastructure.

Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2022)
Journal Article
RECOVERY Collaborative Group, Horby, P. W., Mafham, M., Peto, L., Campbell, M., Pessoa-Amorim, G., Spata, E., Staplin, N., Emberson, J. R., Prudon, B., Hine, P., Brown, T., Green, C. A., Sarkar, R., Desai, P., Yates, B., Bewick, T., Tiberi, S., Felton, T., Baillie, J. K., …Landray, M. J. (2022). Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 399(10325), 665-676. https://doi.org/10.1016/S0140-6736%2822%2900163-5

Background: Casirivimab and imdevimab are non-competing monoclonal antibodies that bind to two different sites on the receptor binding domain of the SARS-CoV-2 spike glycoprotein, blocking viral entry into host cells. We aimed to evaluate the efficac... Read More about Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Elective freezing of embryos versus fresh embryo transfer in IVF: a multicentre randomized controlled trial in the UK (E-Freeze) (2022)
Journal Article
Maheshwari, A., Bell, J. L., Bhide, P., Brison, D., Child, T., Chong, H. Y., Cheong, Y., Cole, C., Coomarasamy, A., Cutting, R., Hardy, P., Hamoda, H., Khalaf, Y., Kurinczuk, J. J., Juszczak, E., Lavery, S., Linsell, L., Macklon, N., Mathur, R., Pundir, J., …Bhattacharya, S. (2022). Elective freezing of embryos versus fresh embryo transfer in IVF: a multicentre randomized controlled trial in the UK (E-Freeze). Human Reproduction, 37(3), 476-487. https://doi.org/10.1093/humrep/deab279

STUDY QUESTION: Does a policy of elective freezing of embryos, followed by frozen embryo transfer result in a higher healthy baby rate, after first embryo transfer, when compared with the current policy of transferring fresh embryos? SUMMARY ANSWER:... Read More about Elective freezing of embryos versus fresh embryo transfer in IVF: a multicentre randomized controlled trial in the UK (E-Freeze).

First‐trimester ultrasound detection of fetal heart anomalies: systematic review and meta‐analysis (2022)
Journal Article
Karim, J. N., Bradburn, E., Roberts, N., Papageorghiou, A. T., Alfirevic, Z., Chudleigh, T., Goodman, H., Ioannou, C., Longworth, H., Nicolaides, K. H., Pandya, P., Smith, G., Thilaganathan, B., Thornton, J., Rivero-Arias, O., Campbell, H., Juszczak, E., Linsell, L., Wilson, E., Hinton, L., …Yaz, G. (2022). First‐trimester ultrasound detection of fetal heart anomalies: systematic review and meta‐analysis. Ultrasound in Obstetrics and Gynaecology, 59(1), 11-25. https://doi.org/10.1002/uog.23740

Objectives: To determine the diagnostic accuracy of ultrasound at 11–14 weeks' gestation in the detection of fetal cardiac abnormalities and to evaluate factors that impact the detection rate. Methods: This was a systematic review of studies evaluati... Read More about First‐trimester ultrasound detection of fetal heart anomalies: systematic review and meta‐analysis.

An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial (2021)
Journal Article
Rochat, T. J., Dube, S., Herbst, K., Hoegfeldt, C. A., Redinger, S., Khoza, T., Bland, R. M., Richter, L., Linsell, L., Desmond, C., Yousafzai, A. K., Craske, M., Juszczak, E., Abas, M., Edwards, T., Ekers, D., & Stein, A. (2021). An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial. Trials, 22(1), Article 914. https://doi.org/10.1186/s13063-021-05672-0

Background: The combination of poverty, HIV and depression in the perinatal period represents a major public health challenge in many Southern African countries. In some areas, up to a third of HIV-positive women experience perinatal depression. Peri... Read More about An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial.

Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
RECOVERY Collaborative Group, Horby, P. W., Pessoa-Amorim, G., Staplin, N., Emberson, J. R., Campbell, M., Spata, E., Peto, L., Brunskill, N. J., Tiberi, S., Chew, V., Brown, T., Tahir, H., Ebert, B., Chadwick, D., Whitehouse, T., Sarkar, R., Graham, C., Baillie, J. K., Basnyat, B., …Landray, M. J. (2022). Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 399(10320), 143-151. https://doi.org/10.1016/S0140-6736%2821%2901825-0

Background
Aspirin has been proposed as a treatment for COVID-19 on the basis of its anti-thrombotic properties. We aimed to evaluate the efficacy and safety of aspirin in patients admitted to hospital with COVID-19.

Methods
In this randomised,... Read More about Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
Horby, P. W., Campbell, M., Spata, E., Emberson, J. R., Staplin, N., Pessoa-Amorim, G., Peto, L., Wiselka, M., Wiffen, L., Tiberi, S., Caplin, B., Wroe, C., Green, C., Hine, P., Prudon, B., George, T., Wight, A., Baillie, J. K., Basnyat, B., Buch, M., …Landray, M. J. (2021). Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Respiratory Medicine, 9(12), 1419-1426. https://doi.org/10.1016/s2213-2600%2821%2900435-5

Background: Colchicine has been proposed as a treatment for COVID-19 based on its anti-inflammatory actions. We aimed to evaluate the efficacy and safety of colchicine in patients admitted to hospital with COVID-19. Methods: In this streamlined, rand... Read More about Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Factors influencing perinatal outcomes in women with preterm preeclampsia: A secondary analysis of the PHOENIX trial (2021)
Journal Article
Fleminger, J., Duhig, K., Seed, P. T., Brocklehurst, P., Green, M., Juszczak, E., Marlow, N., Shennan, A., & Chappell, L. (2021). Factors influencing perinatal outcomes in women with preterm preeclampsia: A secondary analysis of the PHOENIX trial. Pregnancy Hypertension, 26, 91-93. https://doi.org/10.1016/j.preghy.2021.10.002

This secondary analysis of the PHOENIX trial (evaluating planned delivery against expectant management in late preterm preeclampsia) demonstrates that in women who started induction of labour, 63% of women delivered vaginally (56% at 34 weeks’ gestat... Read More about Factors influencing perinatal outcomes in women with preterm preeclampsia: A secondary analysis of the PHOENIX trial.

Reporting transparency and completeness in trials: Paper 1: Introduction - Better reporting for disruptive clinical trials using routinely collected data (2021)
Journal Article
Hemkens, L. G., Juszczak, E., & Thombs, B. D. (2022). Reporting transparency and completeness in trials: Paper 1: Introduction - Better reporting for disruptive clinical trials using routinely collected data. Journal of Clinical Epidemiology, 141, 172-174. https://doi.org/10.1016/j.jclinepi.2021.09.017