Outputs (74)

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.27649

Objectives: 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., …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.

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., …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/NEJMoa2305582

BACKGROUND: 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., …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.

[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., …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., …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., …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.

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., …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/THJY0671

Background: 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.

Methylprednisolone, intravenous immunoglobulin, tocilizimab or anakinra for children with Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS CoV-2 (PIMS-TS, MIS-C) – report from a randomised, controlled, open-label, platform trial (2023)
Journal Article
Faust, S. N., Jones, C. E., Staplin, N., Whittaker, E., Jaki, T., Juszczak, E., …RECOVERY Collaborative Group, R. C. G. (in press). Methylprednisolone, intravenous immunoglobulin, tocilizimab or anakinra for children with Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS CoV-2 (PIMS-TS, MIS-C) – report from a randomised, controlled, open-label, platform trial. Lancet Child and Adolescent Health,

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/10.1177/17407745231204036

Background 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., …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-2023-325871

Objective: 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., …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.

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., …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), https://doi.org/10.3310/WBBW2302

Background 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., …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.

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., … 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., …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., …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., …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).

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., …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., …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., …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., …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., …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., …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., …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., …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., …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., …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

Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results (2021)
Journal Article
Mc Cord, K. A., Imran, M., Rice, D. B., McCall, S. J., Kwakkenbos, L., Sampson, M., …Hemkens, L. G. (2022). Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results. Journal of Clinical Epidemiology, 141, 175-186. https://doi.org/10.1016/j.jclinepi.2021.09.012

Objective: Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries. Study Design and... Read More about Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results.

Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement (2021)
Journal Article
McCall, S. J., Imran, M., Hemkens, L. G., Mc Cord, K., Kwakkenbos, L., Sampson, M., …Juszczak, E. (2022). Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement. Journal of Clinical Epidemiology, 141, 198-209. https://doi.org/10.1016/j.jclinepi.2021.09.011

Objective To describe characteristics of randomized controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using... Read More about Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement.

Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases (2021)
Journal Article
Langan, S. M., Imran, M., Mc Cord, K., McCall, S. J., Kwakkenbos, L., Sampson, M., …Thombs, B. D. (2022). Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases. Journal of Clinical Epidemiology, 141, 187-197. https://doi.org/10.1016/j.jclinepi.2021.09.010

Objective: We evaluated reporting completeness and transparency in randomized controlled trials (RCTs) conducted using administrative data based on 2021 CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTIN... Read More about Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases.

Correction to: Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes (Trials, (2021), 22, 1, (368), 10.1186/s13063-021-05324-3) (2021)
Journal Article
Bell, J. L., Gupta, S., Juszczak, E., Hardy, P., & Linsell, L. (2021). Correction to: Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes (Trials, (2021), 22, 1, (368), 10.1186/s13063-021-05324-3). Trials, 22, Article 609. https://doi.org/10.1186/s13063-021-05409-z

Following the publication of the original article [1], It has come to the authors’ attention that some wording was changed prior to publication of the Statistical Analysis Plan from the original SAP which will be used in their analysis of data.

Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT (2021)
Journal Article
Juszczak, E., Hewer, O., Partlett, C., Hurd, M., Bari, V., Bowler, U., …Stenson, B. (2021). Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT. Trials, 22(1), Article 554. https://doi.org/10.1186/s13063-021-05515-y

Background: Loss to follow-up resulting in missing outcomes compromises the validity of trial results by reducing statistical power, negatively affecting generalisability and undermining assumptions made at analysis, leading to potentially biased and... Read More about Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT.

A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE) [version 1; peer review: awaiting peer review] (2021)
Journal Article
McCarthy, E., O'Keeffe, L., Williamson, P. R., Sydes, M. R., Farrin, A., Lugg-Widger, F., …Kearney, P. M. (2021). A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE) [version 1; peer review: awaiting peer review]. HRB Open Research, 4, 1-7. https://doi.org/10.12688/hrbopenres.13314.1

Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes (2021)
Journal Article
Bell, J. L., Gupta, S., Juszczak, E., Hardy, P., & Linsell, L. (2021). Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes. Trials, 22, Article 368. https://doi.org/10.1186/s13063-021-05324-3

Background: The Baby-OSCAR trial is a multi-centre, randomised, placebo-controlled parallel group trial of early treatment of large patent ductus arteriosus (PDA) with ibuprofen in extremely preterm infants. This paper describes the statistical analy... Read More about Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes.

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial (2021)
Journal Article
Abani, O., Abbas, A., Abbas, F., Abbas, M., Abbasi, S., Abbass, H., …Zyengi, S. (2021). Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial. Lancet, 397(10289), 2049-2059. https://doi.org/10.1016/s0140-6736%2821%2900897-7

Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods: This ran... Read More about Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial.

Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
Abani, O., Abbas, A., Abbas, F., Abbas, M., Abbasi, S., Abbass, H., …Zuriaga-Alvaro, A. (2021). Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 397(10285), 1637-1645. https://doi.org/10.1016/s0140-6736%2821%2900676-0

Background: We evaluated the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19... Read More about Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration (2021)
Journal Article
Kwakkenbos, L., Imran, M., McCall, S. J., McCord, K. A., Fröbert, O., Hemkens, L. G., …Thombs, B. D. (2021). CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration. BMJ, 373, Article n857. https://doi.org/10.1136/bmj.n857

Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the t... Read More about CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration.

Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) (2021)
Journal Article
Imran, M., Kwakkenbos, L., McCall, S. J., McCord, K. A., Fröbert, O., Hemkens, L. G., …Thombs, B. D. (2021). Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). BMJ Open, 11(4), Article e049093. https://doi.org/10.1136/bmjopen-2021-049093

Objectives Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated St... Read More about Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE).

Compression stockings for preventing deep vein thrombosis in airline passengers (2021)
Journal Article
Clarke, M. J., Broderick, C., Hopewell, S., Juszczak, E., & Eisinga, A. (2021). Compression stockings for preventing deep vein thrombosis in airline passengers. Cochrane Database of Systematic Reviews, 2021(4), https://doi.org/10.1002/14651858.cd004002.pub4

Background: Air travel might increase the risk of deep vein thrombosis (DVT). It has been suggested that wearing compression stockings might reduce this risk. This is an update of the review first published in 2006. Objectives: To assess the effects... Read More about Compression stockings for preventing deep vein thrombosis in airline passengers.

Paediatric research in the times of COVID-19 (2021)
Journal Article
Fleming, P. F., Gale, C., Molloy, E. J., Faust, S. N., Costeloe, K., Juszczak, E., & Roehr, C. C. (2021). Paediatric research in the times of COVID-19. Pediatric Research, 90, 267–271. https://doi.org/10.1038/s41390-021-01479-6

The COVID-19 pandemic poses many direct and indirect consequences for children's health and associated research. Direct consequences include participation of children in COVID-19 research trials, pausing other research in children and the potential i... Read More about Paediatric research in the times of COVID-19.

Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial (2021)
Journal Article
Gupta, S., Juszczak, E., Hardy, P., Subhedar, N., Wyllie, J., Kelsall, W., …on behalf of the ‘The Baby-OSCAR Collaborative Group. (2021). Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial. BMC Pediatrics, 21, Article 100. https://doi.org/10.1186/s12887-021-02558-7

Background The question of whether to treat patent ductus arteriosus (PDA) early or wait until symptoms appear remains high on the research agenda for neonatal medicine. Around 7000 extremely preterm babies under 29 weeks’ gestation are born in the... Read More about Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial.

Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
Abaleke, E., Abbas, M., Abbasi, S., Abbott, A., Abdelaziz, A., Abdelbadiee, S., …Zuriaga-Alvaro, A. (2021). Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 397(10274), 605-612. https://doi.org/10.1016/s0140-6736%2821%2900149-5

Summary Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory actions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19. Methods In t... Read More about Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial (2020)
Journal Article
Fleminger, J., Seed, P., Smith, A., Dixon, P., Juszczak, E., Chambers, J., …Chappell, L. (2021). Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial. BJOG: An International Journal of Obstetrics and Gynaecology, 128(6), 1066-1075. https://doi.org/10.1111/1471-0528.16567

Objective: To evaluate whether a particular group of women with intrahepatic cholestasis of pregnancy (ICP), based on their presenting characteristics, would benefit from treatment with ursodeoxycholic acid (UDCA). Design: Secondary analysis of the P... Read More about Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial.

Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19 (2020)
Journal Article
The RECOVERY Collaborative Group, Horby, P., Mafham, M., Linsell, L., Bell, J. L., Staplin, N., …Landray, M. J. (2020). Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19. New England Journal of Medicine, 383(21), 2030-2040. https://doi.org/10.1056/NEJMoa2022926

BACKGROUND Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials. METHODS In this randomized, cont... Read More about Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.

Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2020)
Journal Article
The Recovery Collaborative Group, Horby, P. W., Mafham, M., Bell, J. L., Linsell, L., Staplin, N., …Landray, M. J. (2020). Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 396(10259), 1345-1352. https://doi.org/10.1016/s0140-6736%2820%2932013-4

Summary Background Lopinavir–ritonavir has been proposed as a treatment for COVID-19 on the basis of in vitro activity, preclinical studies, and observational studies. Here, we report the results of a randomised trial to assess whether lopinavir–ri... Read More about Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT) (2020)
Journal Article
Richards, J., Rankin, J., Juszczak, E., Dorling, J., McGuire, W., & Embleton, N. D. (2021). Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT). Archives of Disease in Childhood. Fetal and Neonatal Edition, 106(1), 84-87. https://doi.org/10.1136/archdischild-2020-319031

Objective To explore parents’ perceptions and experience of being approached for enrolment of their preterm infant in more than one trial or study. Design A qualitative study involving 17 in-depth semistructured interviews, with parents who ha... Read More about Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT).

Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report (2020)
Journal Article
Horby, P., Lim, W. S., Emberson, J. R., Mafham, M., Bell, J. L., Linsell, L., …Landray, M. J. (2021). Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report. New England Journal of Medicine, 1-11. https://doi.org/10.1056/NEJMoa2021436

Background Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death. Methods In this controlled... Read More about Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report.

E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan (2020)
Journal Article
Bell, J. L., Hardy, P., Greenland, M., Juszczak, E., Cole, C., Maheshwari, A., …Linsell, L. (2020). E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan. Trials, 21(1), Article 596. https://doi.org/10.1186/s13063-020-04441-9

Background: The E-Freeze trial is a multi-centre randomised controlled trial of fresh versus frozen embryo transfer for women undergoing in vitro fertilisation. This paper describes the statistical analysis plan for the E-Freeze trial. Methods and de... Read More about E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan.

Effect of Dexamethasone in Hospitalized Patients with COVID-19: Preliminary Report (2020)
Preprint / Working Paper
Horby, P., Lim, W. S., Emberson, J., Mafham, M., Bell, J., Linsell, L., …RECOVERY Collaborative Group. Effect of Dexamethasone in Hospitalized Patients with COVID-19: Preliminary Report

Background Coronavirus disease 2019 (COVID-19) is associated with diffuse lung damage. Corticosteroids may modulate immune-mediated lung injury and reducing progression to respiratory failure and death. Methods The Randomised Evaluation of COVID-1... Read More about Effect of Dexamethasone in Hospitalized Patients with COVID-19: Preliminary Report.

Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT) (2020)
Journal Article
Tahir, W., Monahan, M., Dorling, J., Hewer, O., Bowler, U., Linsell, L., …Roberts, T. E. (2020). Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT). Archives of Disease in Childhood. Fetal and Neonatal Edition, 105(6), 587-592. https://doi.org/10.1136/archdischild-2019-318346

Objective: To evaluate the cost-effectiveness of two rates of enteral feed advancement (18 vs 30 mL/kg/day) in very preterm and very low birth weight infants. Design: Within-trial economic evaluation alongside a multicentre, two-arm parallel group,... Read More about Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT).

Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT (2019)
Journal Article
Knight, M., Chiocchia, V., Partlett, C., Rivero-Arias, O., Hua, X., Bowler, U., …Juszczak, E. (2019). Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT. Health Technology Assessment, 23(54), 1-54. https://doi.org/10.3310/hta23540

Background Sepsis is a leading cause of direct and indirect maternal death in both the UK and globally. All forms of operative delivery are associated with an increased risk of sepsis, and the National Institute for Health and Care Excellence’s guid... Read More about Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT.

Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants (2019)
Journal Article
Dorling, J., Abbott, J., Berrington, J., Bosiak, B., Bowler, U., Boyle, E., …Townend, J. (2019). Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants. New England Journal of Medicine, 381(15), 1434-1443. https://doi.org/10.1056/NEJMoa1816654

Background Observational data have shown that slowly advancing enteral feeds in preterm infants is associated with reduced risk for necrotizing enterocolitis but increased risk for late onset sepsis. However, randomized trial data are limited. Me... Read More about Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants.

Very low-dose dexamethasone to facilitate extubation of preterm babies at risk of bronchopulmonary dysplasia: the MINIDEX feasibility RCT (2019)
Journal Article
Yates, H., Chiocchia, V., Linsell, L., Orsi, N., Juszczak, E., Johnson, K., …Turner, M. (2019). Very low-dose dexamethasone to facilitate extubation of preterm babies at risk of bronchopulmonary dysplasia: the MINIDEX feasibility RCT. Efficacy and Mechanism Evaluation, 6(8), 1-52. https://doi.org/10.3310/eme06080

Background: Postnatal corticosteroids are used to improve lung function and reduce the incidence of bronchopulmonary dysplasia (BPD) in preterm babies. However, corticosteroids may be associated with adverse neurodevelopment. Despite a lack of evide... Read More about Very low-dose dexamethasone to facilitate extubation of preterm babies at risk of bronchopulmonary dysplasia: the MINIDEX feasibility RCT.

The WHEAT pilot trial - WithHolding Enteral feeds around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: A multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial (2019)
Journal Article
Gale, C., Modi, N., Jawad, S., Culshaw, L., Dorling, J., Bowler, U., …Juszczak, E. (2019). The WHEAT pilot trial - WithHolding Enteral feeds around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: A multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial. BMJ Open, 9(9), Article e033543. https://doi.org/10.1136/bmjopen-2019-033543

Introduction Necrotising enterocolitis (NEC) is a potentially devastating neonatal disease. A temporal association between red cell transfusion and NEC is well described. Observational data suggest that withholding enteral feeds around red cell trans... Read More about The WHEAT pilot trial - WithHolding Enteral feeds around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: A multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial.

Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial (2019)
Journal Article
Chappell, L. C., Bell, J. L., Smith, A., Linsell, L., Juszczak, E., Dixon, P. H., …Tan, B. (2019). Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. Lancet, 394(10201), 849-860. https://doi.org/10.1016/s0140-6736%2819%2931270-x

Study protocol: E-freeze - freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation (2019)
Journal Article
Maheshwari, A., Bhattacharya, S., Bowler, U., Brison, D., Child, T., Cole, C., …Troup, S. (2019). Study protocol: E-freeze - freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation. Reproductive Health, 16, 1-11. https://doi.org/10.1186/s12978-019-0737-2

Background: Infertility affects one in seven couples; many of these need in vitro fertilisation (IVF). IVF involves external hormones to stimulate a woman's ovaries to produce eggs which are harvested surgically. Embryos, created in the laboratory by... Read More about Study protocol: E-freeze - freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation.

Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial (2019)
Journal Article
Knight, M., Chiocchia, V., Partlett, C., Rivero-Arias, O., Hua, X., Hinshaw, K., …Juszczak, E. (2019). Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial. Lancet, 393(10189), 2395-2403. https://doi.org/10.1016/S0140-6736%2819%2930773-1

Background Risk factors for maternal infection are clearly recognised, including caesarean section and operative vaginal birth. Antibiotic prophylaxis at caesarean section is widely recommended because there is clear systematic review evidence that... Read More about Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial.

Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement (2019)
Journal Article
Juszczak, E., Altman, D. G., Hopewell, S., & Schulz, K. (2019). Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. Journal of the American Medical Association, 321(16), 1610-1620. https://doi.org/10.1001/jama.2019.3087

© 2019 AMA. All rights reserved. Importance: The quality of reporting of randomized clinical trials is suboptimal. In an era in which the need for greater research transparency is paramount, inadequate reporting hinders assessment of the reliability... Read More about Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement.

Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol (2019)
Journal Article
Clarke, P., Craig, J. V., Wain, J., Tremlett, C., Linsell, L., Bowler, U., …Heath, P. T. (2019). Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol. BMJ Open, 9(2), Article e028022. https://doi.org/10.1136/bmjopen-2018-028022

Introduction Catheter-related sepsis is one of the most dangerous complications of neonatal intensive care and is associated with significant morbidity and mortality. Use of catheter-care ‘bundles’ has reduced the incidence of catheter-related seps... Read More about Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol.

Planned delivery or expectant management for late preterm pre-eclampsia: Study protocol for a randomised controlled trial (PHOENIX trial) (2019)
Journal Article
Chappell, L. C., Green, M., Marlow, N., Sandall, J., Hunter, R., Robson, S., …Shennan, A. (2019). Planned delivery or expectant management for late preterm pre-eclampsia: Study protocol for a randomised controlled trial (PHOENIX trial). Trials, 20(1), Article 85. https://doi.org/10.1186/s13063-018-3150-1

Background: Pre-eclampsia is a pregnancy disorder, characterised by hypertension and multisystem complications in the mother. The adverse outcomes of pre-eclampsia include severe hypertension, stroke, renal and hepatic injury, haemorrhage, fetal grow... Read More about Planned delivery or expectant management for late preterm pre-eclampsia: Study protocol for a randomised controlled trial (PHOENIX trial).

Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial (2019)
Journal Article
Griffiths, J., Jenkins, P., Vargova, M., Bowler, U., Juszczak, E., King, A., …Manjunatha, C. (2019). Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial. Lancet, 393(10170), 423-433. https://doi.org/10.1016/s0140-6736%2818%2932221-9

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Background: Infections acquired in hospital are an important cause of morbidity and mortality in very preterm infants. Several small tri... Read More about Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial.

Enteral lactoferrin to prevent infection for very preterm infants: the ELFIN RCT (2018)
Journal Article
Griffiths, J., Jenkins, P., Vargova, M., Bowler, U., Juszczak, E., King, A., …Oddie, S. (2018). Enteral lactoferrin to prevent infection for very preterm infants: the ELFIN RCT. Health Technology Assessment, 22(74), 1-60. https://doi.org/10.3310/hta22740

Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial (2018)
Journal Article
Hartley, C., Moultrie, F., Hoskin, A., Green, G., Monk, V., Bell, J. L., …Slater, R. (2018). Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial. Lancet, 392(10164), 2595-2605. https://doi.org/10.1016/S0140-6736%2818%2931813-0

Background: Infant pain has immediate and long-term effects but is undertreated because of a paucity of evidence-based analgesics. Although morphine is often used to sedate ventilated infants, its analgesic efficacy is unclear. We aimed to establish... Read More about Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial.

Pulse Oximeter Saturation Targeting and Oximeter Changes in the Benefits of Oxygen Saturation Targeting (BOOST)-II Australia and BOOST-II UK Oxygen Trials (2018)
Journal Article
Stenson, B. J., Donoghoe, M., Brocklehurst, P., Davis, P. G., Juszczak, E., Marschner, I. C., …Tarnow-Mordi, W. O. (2019). Pulse Oximeter Saturation Targeting and Oximeter Changes in the Benefits of Oxygen Saturation Targeting (BOOST)-II Australia and BOOST-II UK Oxygen Trials. Journal of Pediatrics, 204, 301-304.E2. https://doi.org/10.1016/j.jpeds.2018.08.033

Infants in the Australian and UK Benefits of Oxygen Saturation Targeting-II trials treated using revised oximeters spent more time within their planned pulse oximeter saturation target ranges than infants treated using the original oximeters (P 

Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration (2018)
Journal Article
Askie, L. M., Darlow, B. A., Finer, N., Schmidt, B., Stenson, B., Tarnow-Mordi, W., …for the Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration. (2018). Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. Journal of the American Medical Association, 319(21), 2190–2201. https://doi.org/10.1001/jama.2018.5725

IMPORTANCE There are potential benefits and harms of hyperoxemia and hypoxemia for extremely preterm infants receiving more vs less supplemental oxygen. OBJECTIVE To compare the effects of different target ranges for oxygen saturation asmeasured b... Read More about Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration.

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials (2017)
Journal Article
Gamble, C., Krishan, A., Stocken, D., Lewis, S., Juszczak, E., Doré, C., …Loder, E. (2017). Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. Journal of the American Medical Association, 318(23), 2337-2343. https://doi.org/10.1001/jama.2017.18556

© 2017 American Medical Association. All rights reserved. IMPORTANCE While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support tr... Read More about Guidelines for the Content of Statistical Analysis Plans in Clinical Trials.

A multicentre, randomised controlled trial of position during the late stages of labour in nulliparous women with an epidural: Clinical effectiveness and an economic evaluation (BUMPES) (2017)
Journal Article
Bick, D., Briley, A., Brocklehurst, P., Hardy, P., Juszczak, E., Lynch, L., …Wilson, M. (2017). A multicentre, randomised controlled trial of position during the late stages of labour in nulliparous women with an epidural: Clinical effectiveness and an economic evaluation (BUMPES). Health Technology Assessment, 21(65), 1-175. https://doi.org/10.3310/hta21650

Background: Epidural analgesia leads to increased risk of instrumental vaginal delivery (IVD). There is debate about whether or not posture in second-stage labour influences the incidence of spontaneous vaginal birth (SVB). Objectives: In nulliparous... Read More about A multicentre, randomised controlled trial of position during the late stages of labour in nulliparous women with an epidural: Clinical effectiveness and an economic evaluation (BUMPES).

Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial (2017)
Journal Article
Brocklehurst, P., Field, D., Greene, K., Juszczak, E., Keith, R., Kenyon, S., …Steer, P. (2017). Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial. Lancet, 389(10080), 1719-1729. https://doi.org/10.1016/s0140-6736%2817%2930568-8

© 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license Background Continuous electronic fetal heart-rate monitoring is widely used during labour, and computerised interpretation could increase its usef... Read More about Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial.

Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial (2015)
Journal Article
Costeloe, K., Hardy, P., Juszczak, E., Wilks, M., & Millar, M. R. (2016). Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial. Lancet, 387(10019), 649-660. https://doi.org/10.1016/s0140-6736%2815%2901027-2

© 2016 Elsevier Ltd. Summary Background Probiotics may reduce necrotising enterocolitis and late-onset sepsis after preterm birth. However, there has been concern about the rigour and generalisability of some trials and there is no agreement about wh... Read More about Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial.

Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes (2014)
Journal Article
Azzopardi, D., Strohm, B., Marlow, N., Brocklehurst, P., Deierl, A., Eddama, O., …Edwards, A. D. (2014). Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes. New England Journal of Medicine, 371(2), 140-149. https://doi.org/10.1056/nejmoa1315788

BACKGROUND: In the Total Body Hypothermia for Neonatal Encephalopathy Trial (TOBY), newborns with asphyxial encephalopathy who received hypothermic therapy had improved neurologic outcomes at 18 months of age, but it is uncertain whether such therapy... Read More about Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes.